APRIL 2011

WEEK ENDING APRIL 30

PRODUCT  Diovan� (valsartan) 160 mg, 7000 Tablets, NOVARTIS label, Rx only; NDC 0078-0359-17. 
CODE Lot F0976, Exp. DEC 2013
RECALLING FIRM/MANUFACTURER Novartis Pharmaceuticals Corp., Suffern, NY, 
REASON Adulterated: presence of foreign tablets; a bottle of Diovan 160mg tablets was found to contain some tablets identified as Diovan� HCT 320/12.5mg
VOLUME OF PRODUCT IN COMMERCE 278 bottles of 7000 bottles
DISTRIBUTION NJ, NV
PRODUCT Chlorzoxazone Tablets USP 500 mg, Rx only, 100 Tablets. 
CODE Lot number 314134 exp 12/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, 
Manufacturer: Barr Laboratories, Inc. (div. Of Teva), Forest, VA. 
REASON Adulterated Presence of Foreign Tablets: Isoniazid residue found in bottle of Chlorzoxazone tablets.
VOLUME OF PRODUCT IN COMMERCE 9,435 bottles
DISTRIBUTION Nationwide
PRODUCT  Levothyroxine Sodium Tablets USP, 150 mcg (0.15 mg), 100 Tablets (10 x 10), NDC 51079-445-20, (Packaged in blister packs, 10 tablets/card, 10 cards/package). 
CODE Lot OA432, Expiration Date: 04/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: UDL Laboratories, Inc., Rockford, IL, 
Manufacturer: Mylan Pharmaceuticals Inc., Morgantown, WV. 
REASON Subpotent (Single Ingredient) Drug: Pharmaceutical did not meet assay specification.
VOLUME OF PRODUCT IN COMMERCE 2,004 packages
DISTRIBUTION Nationwide
PRODUCT   Humira (adalimumab) Pen, 40 mg/0.8mL, 2 single-use prefilled pens, for subcutaneous use only, Rx only, NDC 0074-4339-02 carton, UPC 3 00744 33902. 
CODE Lot 92078LJ40, Exp JUL 2012 and Lot 93085LX40, Exp AUG 2012
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Abbott Park, IL, 
REASON Lack of Assurance of Sterility; some of the Humira Pen Cartons may contain damaged pens which are unusable and may potentially expose a user to broken pieces of glass.
VOLUME OF PRODUCT IN COMMERCE 80,128 cartons
DISTRIBUTION Nationwide, including PR
 
PRODUCT  Mirtazapine Tablets, USP 45 mg, 30 Tablet Bottles; Rx only. NDC 13107-032-30. 
CODE
Lot Number: 032090003A Exp. date 04/2011 032090011A, 032090009A, Exp. date: 10/2011; Lot Number: 032100006A, Exp. date: 12/2011; Lot Number: 032100012A, Exp. date: 2/2012; Lot Number: 032100019B, Exp. date: 04/12; Lot Number: 032100021A, 032100021B, 032100022A, 032100022B, Exp. date: 06/2012; Lot Number: 032100025A, Exp. date: 07/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurobindo Pharmaceutical USA, Inc., Dayton, NJ,  
Manufacturer: Aurolife Pharma LLC, Dayton, NJ. 
REASON Impurities/Degradation Products: Recall initiated due to the product not meeting a specification for a known degradation product during routine stability tasting.
VOLUME OF PRODUCT IN COMMERCE 66,915 bottles
DISTRIBUTION Nationwide
PRODUCT   Foradil Aerolizer (formoterol fumerate inhalation powder), 12 mcg per capsule, 60 Capsules (10 Blister strips of 6) with 1 Aerolizer Inhaler per carton, Rx only, NDC 0085-1401-01, UPC 3 0085-1401-01 9.
CODE Lot F0008, Exp 04/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals Corp. Suffern, NY, 
Manufacturer: Novartis Pharma Stein AG, Stei, Switzerland ;
Novartis Pharmaceuticals Corp., Suffern, NY.
REASON Out Of Specification Particle Size Distribution Test: During recent testing of Foradil Aerolizer Lot F0008 an out of specification (OOS) result was reported for the Particle Size Distribution Test.
VOLUME OF PRODUCT IN COMMERCE 62,323 cartons
DISTRIBUTION Nationwide

Ethos Environmental, Inc. Issues a Recall of Specific Lots Of The Dietary Supplement Regenerect 

Ethos Environmental, Inc. is recalling the company’s dietary supplement sold under the brand name Regenerect with the following Lot Numbers:

Regenerect Lot Numbers:
100521 - blue capsule sold individually in foil packets, expires 5/2012
112850 - clear capsule sold individually in foil packets, expires 11/2013

Ethos Environmental, Inc. is conducting a recall because lab analysis has confirmed the presence of Sulfoaildenafil, an analogue of Sildenafil, making these products unapproved new drugs. 

Ethos Environmental, Inc. has distributed Regenerect via sales made over the internet to consumers in the United States of America and Puerto Rico.

Ethos Environmental, Inc. advises any customers in possession of the Regenerect product matching the lot numbers above to return any unused product for an exchange, or a full refund, to the company directly. 

Customers can call (866) 925-9553 (Monday through Friday from 6am to 6pm Pacific Time) for instructions on the return and exchange/refund process.

WEEK ENDING APRIL 23

American Regent Initiates Recall of Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial 

American Regent is conducting a recall of:

Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10mL) 10mL Single Dose Vial NDC 0517-6610-25, Lot # 9409, Exp. Date June 2011.

This recall was initiated because some vials of this lot were observed to contain particulates. 

Ammonium Molybdate Injection, USP is indicated for use as a supplement to Total Parenteral Nutrition (TPN) solutions. Administration of Molybdenum in TPN solutions helps to prevent depletion of endogenous stores and subsequent deficiency symptoms.

The product was distributed to wholesalers and distributors nationwide.

American Regent is notifying its distributors and consumers by email, facsimile and/or overnight courier and is arranging for return of all recalled product. Consumers/distributors/retailers that have product which is being recalled should stop use.

American Regent will credit accounts for all returned product with this lot # 9409. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM ET.

Hospitals, infusion centers, clinics and healthcare providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at: 1-877-788-3232.  

PRODUCT Zolpidem Tartrate tablets, 10 mg, 100 count bottle, Rx only; NDC 0093-0074-01. 
CODE Lot number 10Z005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, 
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. 
REASON CGMP Deviations: Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".
VOLUME OF PRODUCT IN COMMERCE 62,803 units
DISTRIBUTION Nationwide
PRODUCT   
1) Pravastatin Sodium Tablets USP, 20 mg, a) 1000- count bottle (NDC 0093-7201-10), b) 90-count bottle (NDC 0093-7201-98), Rx only.
2) Pravastatin Sodium Tablets USP, 40 mg, 1000- count bottle, Rx only; NDC 0093-7202-10. 
CODE
1) a) Lot # 04Y223; b) Lot #04Y233;
2) Lot # 05Y219
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, 
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. 
REASON CGMP Deviations: Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".
VOLUME OF PRODUCT IN COMMERCE 12,552 units
DISTRIBUTION Nationwide
PRODUCT I.V. PREP (Isopropyl Alcohol 70% v/v) Antiseptic Wipe, 50 wipes per carton, NDC 50484-212-00, UPC 3 50484 21200 1, Product Code #59421200. 
CODE
Lots: 9K143, Exp 09/12; 0F131, 0F140, Exp 05/13; 0G249, 0G255, 0G256, 0G259, Exp 06/13; 0K139, 0K140, 0K141, 0K193, 9K141, 9K142, Exp 09/13; 0M180, 0M216, Exp 11/13; 1A242, 1A213, Exp 12/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew Inc., Saint Petersburg, FL, 
Manufacturer: H & P Industries, Inc., Hartland, WI. 
REASON This action is being taken "due to an abundance of caution" as this product is manufactured by H&P Industries dba The Triad Group in the same location which manufactures various sterile alcohol wipes/swabs and swabsticks that are currently being recalled for suspected bacterial contamination.
VOLUME OF PRODUCT IN COMMERCE 250,340 cartons
DISTRIBUTION Nationwide
PRODUCT Carvedilol Tablets USP, 12.5 mg, Rx only, 500 count bottle, NDC: 0093-7295-05.
CODE Lot number: 04C118, Exp. date: 7/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,  
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. 
REASON CGMP Deviations: Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry”.
VOLUME OF PRODUCT IN COMMERCE 5,568 Bottles
DISTRIBUTION Nationwide
PRODUCT Diovan� (valsartan) 160 mg, 7000 Tablets, NOVARTIS label, Rx only, NDC 0078-0359-17. 
CODE Lot F0976, Exp. DEC 2013
RECALLING FIRM/MANUFACTURER Novartis Pharmaceuticals Corp., Suffern, NY, 
REASON Adulterated: presence of foreign tablets; a bottle of Diovan 160mg tablets was found to contain some tablets identified as Diovan� HCT 320/12.5mg.
VOLUME OF PRODUCT IN COMMERCE 278 bottles of 7,000 bottles
DISTRIBUTION NJ and NV for further distribution to mail-order customers
PRODUCT Gemfibrozil tablets USP, 600 mg, 60 count bottle, Rx only; NDC 0093-0670-06. 
CODE Lot # 01G495
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, 
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. 
REASON CGMP Deviations: Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".
VOLUME OF PRODUCT IN COMMERCE 17, 667 units
DISTRIBUTION Nationwide and PR

WEEK ENDING APRIL 16

PRODUCT Actavis Fentanyl Transdermal System 25 mcg/h strength, Rx; NDC 67767-120-18. 
CODE Lot number 30041, Exp. 12/2011 Lot number 30049, Exp. 12/2011 Lot number 30066, Exp. 12/2011 Lot number 30096, Exp. 01/2012 Lot number 30097, Exp. 02/2012 Lot number 30123, Exp. 01/2012 Lot number 30241, Exp. 02/2012 Lot number 30256, Exp. 02/2012 Lot number 30257, Exp. 03/2012 Lot number 30258, Exp. 03/2012 Lot number 30349, Exp. 03/2012 Lot number 30350, Exp. 03/2012 Lot number 30391, Exp. 03/2012 Lot number 30392, Exp. 04/2012 Lot number 30429, Exp. 04/2012 Lot number 30430, Exp. 04/2012 Lot number 30431, Exp. 04/2012 Lot number 30517, Exp 04/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Actavis South Atlantic LLC, Sunrise, FL, 
Manufacturer: Corium International, Inc., Grand Rapids, MI. 
REASON Exceeds Dissolution Specification; high dissolution results were obtained during stability testing
VOLUME OF PRODUCT IN COMMERCE 213,768 boxes
DISTRIBUTION Nationwide
PRODUCT REVIVEXXX Herbal Supplement, Extra Strength Sexual Enhancer for Men, sublingual (under tongue) - 1 tablet, UPC 8 35470 00207 8. \
CODE All lots with expiration dates including and prior to August 2013.
RECALLING FIRM/MANUFACTURER
Recalling Firm: EZVILLE LTD, Ronkonkoma, NY, 
Manufacturers: Changsha Foreign Economic Relations and Trade Corp., Changsha, Hunan, China. 
REASON Marketed Without an Approved NDA/ANDA: Product found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making REVIVEXXX an unapproved drug.
VOLUME OF PRODUCT IN COMMERCE 3,864 blister packs
DISTRIBUTION Nationwide and Aruba
PRODUCT   
1) Rock Hard Extreme Capsules Dietary Supplement, All Natural herbal Aphrodisiac, 1 count blister pack and 10-count bottles, UPC 7 97882 13575 2.
 
2) Passion Coffee, Single Packets, Net weight: 17g/sachet, UPC 7 97882 00001 2. 
CODE
1) Lot # 1152010, Exp. date: 01/13;
2) UPC only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Planet Advertising Group Inc. DBA Drive Total Energy, San Diego, CA, 
Manufacturer: Colman Botanicals, Inc., Margate, FL. 
REASON Marketed Without an Approved NDA/ANDA: product found to contain sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making this product an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE 3749 (3446 blister packs, 14 x 10 ea bottles, 93 packets, 7 x 10 packs)
DISTRIBUTION Nationwide
PRODUCT Reversitol Dietary Supplement Capsules, 624mg proprietary blend, 60 capsules/bottle, Anti-Aromatase, Testosterone, UPC 8 5450300113 8.
CODE All lot/codes mfr through 12/09
RECALLING FIRM/MANUFACTURER Tribravus Enterprises, LLC, Vista, CA, 
REASON Marketed Without an Approved NDA/ANDA; product contains 6-Etioallochol-1, 4-Diene-3, 17-Dione which is a synonym of ATD. ATD is classified as an aromatase inhibitor.
VOLUME OF PRODUCT IN COMMERCE 29,758 bottles
DISTRIBUTION Nationwide
 
PRODUCT Simponi (golimumab), 50 mg/0.5 mL, one single dose SmartJect autoinjector, Rx only, NDC 57894-070-02. 
CODE Lot #: 09D071.AC, Exp 08/11
RECALLING FIRM/MANUFACTURER Centocor Ortho Biotech Services LLC, Malvern, PA, 
REASON Miscalibrated and/or Defective Delivery System; product may not deliver the full dose.
VOLUME OF PRODUCT IN COMMERCE 839 pre-filled syringes
DISTRIBUTION Nationwide
PRODUCT Lisinopril Tablets USP, 30 mg, 100 count plastic bottles, Rx only, NDC: 68180-516-01. 
CODE Batch No. 3104749, Exp. date: 10/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lupin Pharmaceuticals Inc., Baltimore, MD,
Manufacturer: Lupin Limited, Verna, Salcette, Goa, India. 
REASON Adulterated Presence of Foreign Tablets: Product may contain foreign tablets.
VOLUME OF PRODUCT IN COMMERCE 14,256 bottles
DISTRIBUTION Nationwide
PRODUCT CREON (pancrelipase) Delayed Release Capsules, 6000 USP units in 12 count professional sample bottles only, NDC 0032-1206-46, Rx Only. 
CODE Lot numbers: 44840, 45114 and 45398
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, 
Manufacturer: Solvay Pharmaceuticals Inc., Marietta, GA. 
REASON Subpotent; 12 month, 18 month and 24 month stability time-points.
VOLUME OF PRODUCT IN COMMERCE 20377 12-count bottles
DISTRIBUTION Nationwide
PRODUCT Methylprednisolone Tablets USP, 8 mg, packaged 25 tablets/bottle, Rx only; NDC 59746-002-04
CODE Lot 9P370 exp:07/11
RECALLING FIRM/MANUFACTURER Cadista Pharmaceuticals Inc., Salisbury, MD, 
REASON Adulterated Presence of Foreign Tablets: A foreign yellow oblong Meclizine 25 mg tablet was found in a 25-count bottle of white oblong Methylprednisolone 8 mg tablets.
VOLUME OF PRODUCT IN COMMERCE 8,724 bottles
DISTRIBUTION Nationwide
PRODUCT Topiramate Tablets, 25 mg, 1000 count bottle, Rx only; NDC 0093-0155-10. 
CODE Lot numbers 28T033 and 28T034
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville. PA, .
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. 
REASON CGMP Deviations; Firm's laboratory investigations were not performed in accordance with the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".
VOLUME OF PRODUCT IN COMMERCE 7,770 bottles
DISTRIBUTION Nationwide
PRODUCT   
1) Tjet Demonstration Kits. The kit contains: 1 needle free injection device, 5 needle free injection heads, 2 vial adapters, 1 user manual, 1 patient welcome letter, and 1 Tev-Tropin Package Insert.  
2) Tev-Tropin Vial Adapters, contains 10 adapters. 
CODE
1) Lot number 000923 exp 5/2014;
2) Lot number 000924 exp 7/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferring Pharmaceuticals Inc., Parsippany, NJ, 
Manufacturer: Minnesota Rubber and Plastics, Minneapolis, MN. 
REASON Labeled with Incorrect Expiration Date; Tjet Demonstration Kits labeled as 05/2014 (should be 4/2013); Tev-Tropin Vial Adapters labeled as 07/2014 (should be 5/2014).
VOLUME OF PRODUCT IN COMMERCE 88 kits; 736 adapters
DISTRIBUTION MS
PRODUCT Acetadote (acetylcysteine) Injection, 200mg/mL, (6g/30mL), 30 mL Sterile, Rx Only; NDC 66220-107-30. 
CODE Lot #: 090304, 090331, Exp 2/11; 090401 Exp 03/11; 090511, Exp 04/11; 090602, 090616, Exp 05/11.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cumberland Pharmaceuticals Inc., Nashville, TN, 
Manufacturer: Bioniche, Teo, Inverin, Ireland. 
REASON Presence of Particulate Matter; A small number of vials were found to contain particulate matter.
VOLUME OF PRODUCT IN COMMERCE 20,670 vials
DISTRIBUTION Nationwide
 
PRODUCT DynaCirc CR (isradipine) Controlled Release Tablets, 5 mg, packaged in 30 tablet bottles, Rx only; NDC 0173-0784-01. 
CODE Lots: 10090217 and 10097805
RECALLING FIRM/MANUFACTURER
Recalling Firm: GlaxoSmithKline Inc., Zebulon, NC, by letter on/about March 18, 2011. 
Manufacturers: Patheon Pharmaceuticals Inc., Cincinnati, OH;
Novartis Consumer Health, Lincoln, NB.
REASON Failed USP dissolution test requirements.
VOLUME OF PRODUCT IN COMMERCE 24,782 bottles
DISTRIBUTION Nationwide
PRODUCT   
1) Metformin HCl Tablets USP, 500 mg, packaged in 500 count bottles, Rx only, NDC 0378-7185-05.  
2) Metformin HCl Tablets USP, 1000 mg, packaged in 500 count bottles, Rx only, NDC 0378-7187-05. 
CODE
1) Lots: 1037223 EXP MAY 2012 1037224 EXP MAY 2012 1037239 EXP MAY 2012;
2) Lots: 1029953 EXP JAN 2012 1042806 EXP JUL 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mylan Pharmaceuticals Inc., Morgantown, WV, 
Manufacturer: Matrix Laboratories Limited, (Nashik FDF), Nashik, India. 
REASON Superpotent (Single Ingredient Drug): Pharmaceutical available by prescription only may contain oversized tablets.
VOLUME OF PRODUCT IN COMMERCE 548,601 bottles
DISTRIBUTION Nationwide

Ortho-McNeil Neurologics Recalls Two Lots of TOPAMAX®

Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is recalling two lots of TOPAMAX® (topiramate) 100mg Tablets. These two lots were shipped between 10/19/2010 and 12/28/2010 and distributed in the U.S. and Puerto Rico. The recall stems from uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

Package Description
NDC Code
Lot Number
Expiry
TOPAMAX® (topiramate) TABLETS 100mg Bottles of 60 Tablets
50458-641-65
0KG110
06-2012
0LG222
09-2012

TOPAMAX® 100mg Tablets are yellow debossed with “OMN” on one side and “100” on the other. While no consumer actions are required, patients taking TOPAMAX® 100mg Tablets who experience an uncharacteristic odor associated with their medication should return the tablets to their pharmacist, and contact their healthcare professional if they have questions. Patients or healthcare professionals can contact the TOPAMAX® Line at 1-866-536-4398 (Monday – Friday, 9 am – 5pm ET). Additional information about the recall can be found on Topamax.com, RxForSafety.com, and OrthoMcNeilNeurologics.com.   

 

WEEK ENDING APRIL 9

PRODUCT Walgreens Infant & Children, Glycerin Suppositories, Laxative, 12 suppositories, 33-1112-WAL, OTC; UPC 311917 115146. 
CODE LOT OD 118, EXP 04/13
RECALLING FIRM/MANUFACTURER H & P Industries, Inc., Hartland, WI, 
REASON This recall has been initiated by Triad Group due to their unintended failure to conduct a planned re-inspection of this lot for particulate contamination.
VOLUME OF PRODUCT IN COMMERCE 737 cases, 48 jars per case, 12 suppositories per jar
DISTRIBUTION AZ, FL, CA, IL, OH PA, SC, TX, WI

PRODUCT Sodium Thiosulfate Injection, USP 10%, 100 mg/mL (1 g/10 mL), 10 mL Single Dose Vial, packaged in 5 x 10 mL Single Dose Vials per carton, Rx only, NDC 0517-1019-05. 
CODE Lot# 0056, Exp 01/12
RECALLING FIRM/MANUFACTURER Luitpold Pharmaceuticals, Inc., Shirley, NY,
REASON Presence of Particulate Matter: Some vials exhibit translucent visible particles consistent with glass delamination.
VOLUME OF PRODUCT IN COMMERCE 31,105 vials
DISTRIBUTION Nationwide

PRODUCT Innohep (tinzaparin sodium injection) multi-dose vial; 20,000 IU/mL, Rx only, NDC 5022-342-53 and NDC 50222-342-08. 
CODE Lot Number Expiration Date 10 x 2 ml vials, lot number: DC3957 2-2011 DC5102 2-2011 DC6685 3-2011 DC7549 4-2011 DC7118 4-2011 DC8258 5-2011 DC7550 5-2011 DC9390 7-2011 DC9391 7-2011 DC9651 7-2011 DD0713 9-2011 DE4704 1-2013 DE4708 2-2013 DE4957 3-2013; 1 X 2 ml vial, lot number: DC3381 2-2011 DC6985 4-2011 DC8228 5-2011 DC9158 7-2011 DC9874 7-2011 DC9873 8-2011 DE4705 1-2013 DE6288 3-2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leo Pharma Inc., Parsippany, NJ, 
Manufacturer: Leo Pharma A/S, Ballerup, Denmark. 
REASON Presence of particulate matter; glass, metal.
VOLUME OF PRODUCT IN COMMERCE 72,851 units
DISTRIBUTION PA, NJ

PRODUCT Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus and 22 mEq/5 mL Potassium, 5 mL Single Dose Vial, packaged in 25 x 5 mL Single Dose Vials per carton, Rx only, NDC 0517-2305-25. 
CODE Lot # 0048, Exp 01/12
RECALLING FIRM/MANUFACTURER Luitpold Pharmaceuticals, Inc., Shirley, NY, 
REASON Presence of Particulate Matter: Some vials exhibit translucent visible particles consistent with glass delamination.
VOLUME OF PRODUCT IN COMMERCE 151,800 vials
DISTRIBUTION Nationwide

PRODUCT Flexeril, 10 mg, bottles of 100, NDC # 50580-874-11. 
CODE Lot # SBC0548, Expiration 01/31/2011 and lot # SDC0149, Expiration 3/2011
RECALLING FIRM/MANUFACTURER Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc., Fort Washington, PA, 
REASON Product is being recalled due to cGMP deviations. Review of past production records found instances were equipment cleaning procedures were insufficient or that cleaning was not adequately documented.
VOLUME OF PRODUCT IN COMMERCE 52,406 units
DISTRIBUTION Nationwide

PRODUCT Triamterene and Hydrochlorothiazide Tablets, USP, 75mg/50mg, Rx only 500 Tablets. NDC 0781-1008-05. 
CODE Lot 192733 Exp. 02/13
RECALLING FIRM/MANUFACTURER Sandoz Inc., Broomfield, CO, 
REASON CGMP Deviations: the firm states that the root cause is related to an event that occurred during the compression process for the batch.
VOLUME OF PRODUCT IN COMMERCE 5427 / 500 count bottles
DISTRIBUTION Nationwide

PRODUCT Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, a) 5 mL bottle (NDC 16571-135-50, UPC 3 16571 13550 9), b) 10 mL bottle. NDC 16571-135-10, UPC 3 16571 135110 3, Rx only. 
CODE Lot #'s: a) NCW0081, NCW0082, Exp 07/12; b) NCW0091, Exp 08/12
RECALLING FIRM/MANUFACTURER FDC Limited, Aurangabad, Maharashtra State, India,
REASON Impurities/Degradation Products: The recall of the listed batches of product was initiated due to an Out-of-Trend impurity level observed during the stability testing of the lots, however the firm later reported that the product is now testing with Out-of-Specification results.
VOLUME OF PRODUCT IN COMMERCE 4,812 bottles
DISTRIBUTION Nationwide

PRODUCT
1) Zanaflex Capsules, tizanidine hydrochloride, 4 mg, bottles of 150 capsules, Rx only, NDC/UPC Code 10144-604-15. 

2) Zanaflex Capsules, tizanidine hydrochloride, 2 mg, bottles of 150 tablets, Rx only, NDC/UPC Code 10144-602-15. 
CODE
1) Lot: 9P445 exp 8/2014 and Lot: 9M227 exp 5/2014
2) Lot: 0L371
RECALLING FIRM/MANUFACTURER
Recalling Firm: Acorda Therapeutics Inc., Hawthorne, NY, 
Manufacturer: Elan Pharma Ltd., Westmeath, Ireland;
Manufacturer: Elan Holdings, Inc., Gainesville, GA. 
REASON Subpotent; empty capsules were found in certain lots.
VOLUME OF PRODUCT IN COMMERCE 21,922 bottles
DISTRIBUTION Nationwide

PRODUCT Cabergoline Tablets, USP, 0.5 mg, 8 count bottles, Rx only, NDC 0093-5420-88. 
CODE Lot #s: 3A902071, Exp 02/11; 3A903022, Exp 03/11; 3A903119, Exp 03/11
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA, Inc., Sellersville, PA, 
Manufacturer: Ivax-CR A.S., Opava-Komarov, Czech Republic. 
REASON Impurities/Degradation Products: Specified lots of this product have the potential to not meet stability specifications for impurities.
VOLUME OF PRODUCT IN COMMERCE 40,067 bottles
DISTRIBUTION Nationwide

Centurion Medical Products Initiates  Recall of Customized Convenience Kits 

Centurion Medical Products Corporation, of Williamston, Michigan, is recalling certain customized convenience kits that contain Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials manufactured by Luitpold Pharmaceuticals, Inc., and distributed by American Regent, Inc. This action is in response to American Regent’s recall of three lots of vials because some may contain visible particulates.

Customers that have any of the affected products should not use them.

Customers with questions should contact Centurion’s Recall Coordinator at 800-248-4058, extension 1156 (Monday through Friday, 7:00 am through 3:30 pm ET).   

Recalled Kits

Material Material Describtion Batch
CVI2615 PICC INSERTION TRAY 2010050750
301-00 INSERTION TRAY 2009092850
2010012950
2010030150
2010043050
2010061850
2010062950
2010082650
CVI2050 PICC LINE TRAY 2010071650
CVI2590 INSERTION/PPE KIT 2009102850
2009121750
2010030250
2010061550
2010072650
CVI2685 PICC INSERTION TRAY 2009102650
2010021950
2010040550
2010040850
CVI2690 PICC INSERTION TRAY 2010050750
2010080950
2010081150
2010090750
CVI2795  PICC INSERTION TRAY 2009100950
2009111250
2010010650
2010011150
2010021150
2010022250
2010041250
2010091050
 CVI2880  PICC LINE KIT 2009092550
2009111850
2009121150
2009122150
2010032550
2010040550
2010050450
2010052850
2010082650
 CVI2960 PICC LINE TRAY 2010010750
2010031150
2010032250
2010051350
2010062950
2010090150
CVI2970 UNIVERSAL INSERTION / PROTECTION KIT 2010011250
2010020150
2010051950
2010060450
2010071250
2010080450
CVI2980 PICC INSERTION TRAY 2010020850
2010030950
2010031650
2010041350
2010050450
CVI3015 ADULT PICC INSERTION TRAY 2009093050
2009113050
2009120850
2009123050
2010020350
2010030550
2010042050
2010050750
2010061050
2010072350
2010090750
CVI3030 TEMPORARY PACEMAKER INSERTION TRAY 2010022350
2010043050
CVI3070 CENTRAL LINE PROCEDURE TRAY 2009092450
2009100150
2010020950
CVI3105 PICC INSERTION KIT 2010011350
2010012050
2010020850
CVI3145 CENTRAL LINE INSERTION BUNDLE 2009102950
2010010650
2010011350
2010021150
2010022450
2010051850
2010061550
2010072050
2010081850
2010091750
CVI3155 PICC INSERTION TRAY 2009101250
2009120250
2009123150
2010022350
2010031950
2010041650
2010060750
2010072150
2010081350
2010090750
CVI3270 PICC INSERTION TRAY 2009101250
2009110250
2009112350
2009122850
2010031950
2010041550
2010051150
2010070950
2010082050
CVI3325 PICC LINE INSERTION KIT 2009102650
CVI3435 INTRODUCER BUNDLE 2010060450
2010081250
2010090750
 CVI680B CENTRAL CATHETER INSERTION TRAY 2009091850
2009111150
2009120950
2010011950
2010020250
2010031150
2010052750
2010072350
2010081250
2010090250
 CVI980 PICC INSERTION TRAY 2009092550
2009103050
2009112350
2009121850
2010020550
DT10010 PICC/MIDLINE INSERTION TRAY 2009093050
2009101550
2009112450
DT10510 INSERTION/PROTECTION KIT 2009092550
2009102950
2009111350
2009121550
2009121650
2010012250
2010031850
2010042250
2010051350
2010072850
2010082550
DT10595 CENTRAL LINE INSERTION TRAY 2010030550
2010080350
2010090150
DT10605 INSERTION/PROTECTION KIT 2009091750
2009101550
2009110650
2009111950
2009120450
2009122850
DT10605 INSERTION/PROTECTION KIT 2010012850
2010041650
2010052750
2010070750
2010080250
DT11315 CENTRAL LINE ACCESSORY PACK 2010010550
2010020150
2010030850
2010032450
2010050450
2010061450
2010072250
 DT11375  PICC PROCEDURE TRAY 2009101950
2009121850
2010010850
2010021250
2010030350
2010041650
2010063050
2010072150
2010091050
DT11520  CVC ACCESSORY KIT 2009120850
2009122950
2010031750
2010040850
2010052550
2010062250
2010081250
2010092150
DT11980 VAD TRAY 2009092450
2009102950
2009120950
2010012750
2010021150
2010042250
2010052450
2010062450
2010072750
2010081950
DT12050 PORT ACCESS TRAY 2009100950
2009103050
2009120750
2009122850
2010060350
2010062250
2010070950
2010081850
2010082450
2010082650
DT12210 CENTRAL LINE PROCEDURE KIT 2010062150
DT12400 PORT ACCESS TRAY 2009100950
2009112550
2010010550
2010020950
2010030450
2010040850
2010042350
2010052150
2010081150
2010091750
DT12405 NERVE BLOCK TRAY 2009092550
DT12910 PORT ACCESS TRAY W/ SECUREVIEW 2009091750
2009101550
2009102950
2010020450
2010030150
2010041650
2010052050
2010062850
2010072850
DT13225 TRIPLE LUMEN INSERTION/PROTECTION ( P/S) 2009120350
2009123150
2010031750
2010050550
2010052650
2010072150
2010090850
 DT13770  DRESSING CHANGE TRAY 2009100750
2009102150
DT14425 PICC INSERTION BUNDLE 2010020950
2010052550
2010062950
2010071450
2010081350
2010092250
DT14430 PICC PROCEDURE TRAY 2009101450
DT14805 PICC PROCEDURE TRAY 2010040850
DT14875 OUT-PATIENT PORT ACCESS DRESSING TRAY 2010030850
2010042850
2010051450
2010060350
2010061650
2010071550
2010080550
DT14880 IN-PATIENT PORT ACCESS DRESSING TRAY P/S 2010031250
2010032250
2010060150
2010061050
2010080450
2010090950
 DT5035 PORT ACCESS TRAY 2009122950
2010081950
DT5245 PORT ACCESS TRAY 2009113050
2009122950
2010012950
2010042050
2010043050
2010060950
2010082650
DT6110 PORT ACCESS TRAY WITH HUBER NEEDLE
DT6475B PORT ACCESS TRAY 2009091550
2009111850
2010012050
2010022450
2010041550
2010051850
2010062950
2010080450
2010090850
DT6755 VAD DRESSING TRAY 2009101450
2009120250
2009122950
2010081850
DT6765 PORT CATH TRAY 2009100550
2009110350
2009120450
2009122850
2010012950
2010032350
2010050450
2010060850
2010091450
DT6945B PORT CATH TRAY 2009092250
2009100850
2009111150
2009122250
2009123150
2010020550
2010041550
2010052750
2010072750
2010082650
DT7035 VAD INSERTION TRAY 2009110650
2009111650
DT7135 PORT ACCESS TRAY 2009110650
2010012550
2010022650
2010032250
2010040750
2010061850
DT7150 PORT ACCESS TRAY 2009101950
2010011150
2010041650
2010060150
2010060350
2010081950
2010082650
DT7550 PORT ACCESS TRAY 2009100750
2009101950
2010010550
2010021950
2010031250
2010041250
2010052150
2010080350
2010090750
 DT7890 PORT ACCESS TRAY 2009101950
2010010650
DT8415 PORT ACCESS TRAY W/SORBAVIEW SHIELD 2009092450
2009101350
2009110650
2009121550
2010020950
2010021850
2010031950
2010041550
2010052150
2010080350
DT8915 VAD KIT 2010090750
2010111550
2010112950
 DT9155  PORT ACCESS TRAY W/SORBAVIEW&CHLORAPREP 2009100550
2009111650
2009121550
2010021950
2010040550
2010060950
2010062850
DT9155 PORT ACCESS TRAY 2009092450
2010021050
2010042250
2010051950
2010060950
DT9345E DRESSING CHANGE TRAY 2009092850
2010012050
2010022650
2010032950
2010060250
2010072150
2010081850
DT9460 PICC INSERTION 2009102350
2009110350
2009111950
2009112050
2010020950
DT9750 VAD ACCESS TRAY 2009120250
2010051850
ECVC1020 TRIPLE LUMEN BUNDLE KIT W/CATHETER P/S 2010042650
ECVC1040 CENTRAL LINE INSERTION BUNDLE 2010032350
2010042750
2010062150
2010062550
2010090350
ECVC1140 TRIPLE LUMEN INSERTION KIT 2010052850
ECVC1285 TRIPLE LUMEN CENTRAL LINE BUNDLE 2010091650
ECVC215 CVC MULTI-LUMEN INSERTION BUNDLE 2009110550
ECVC270 CENTRAL LINE INSERTION BUNDLE 2009102350
2009121750
2010020350
2010021050
2010030150
2010041250
ECVC280 CVC MULTI LUMEN INSERTION BUNDLE 2010020450
2010031650
2010042050
2010081650
2010082550
2010091750
ECVC355 CVC INSERTION BUNDLE 2009100650
2009110250
2009121150
2010072850
ECVC405 P-CVC MULTI-LUMEN INSERTION BUNDLE 2009102050
2009110550
2010040950
2010041450
2010071250
2010072850
2010082550
ECVC465 CVC TRIPLE LUMEN KIT 2009100750
2009102350
2010012250
2010012550
2010063050
2010092950
ECVC470 CVC BUNDLE 2010031250
2010062850
 ECVC540  CVC TRIPLE LUMEN BUNDLE KIT 2009102050
2010011250
ECVC575 MULTI-LUMEN CVC TRAY 2010011350
2010073050
2010081250
ECVC590 CENTRAL VENOUS CATH BUNDLE TRAY 2009112050
2010020950
2010032250
ECVC895 CENTRAL LINE INSERTION BUNDLE 2010020450
2010061550
ECVC950 CVC TRIPLE LUMEN BUNDLE, 7FR/16CM 2010060750
2010092950
ECVC955 CVC TRIPLE LUMEN BUNDLE, 7FR/20CM 2010052850
2010072850
2010092950
HT1995A ;V.A.D.TRAY 2009102950
2009121550
2010012250
2010021550
2010033050
2010042850
2010060850
2010061050
2010082650
2010090850
 HT2415 VAD ACCESS KIT 2010090150
2009092350
2009101950
2009111850
2010012950
2010041350
2010060450
2010061650
2010072250
2010090750
HT2430A V.A.D.TRAY 2009100850
2009101950
2009102850
2009110350
2009112450
2010060850
2010072150
2010090250
HT2440A VAD ACCESS TRAY 2009100950
2009102250
2009112450
2009121650
2010030250
2010032350
2010041650
2010052150
2010062450
2010082650
2010091750
 HT2480 V.A.D. TRAY 2009111850
 ULT2170  ULTIMATE LINE TRAY 2010020350
2010021650
2010030150
2010071350
ULT2170A ULTIMATE LINE TRAY 2009100850
2009102650
2009112550
2009121650
2010012650
2010020450
2010020850
2010031950
2010051350
2010082750
 ULT2175 ULTIMATE LINE TRAY 2010021550
2010042850
2010052650
2010070850
2010081950

WEEK ENDING APRIL 2

PRODUCT Arthrotec 75 (75 mg diclofenac sodium/200 mcg misoprostol), 75 mg/200 mcg tablets, 60-tablet count bottle, Rx only, NDC 0025-1421-60, UPC 3 0025-1421-60 0.
CODE Lot #: C091403, Exp 06/13; C091600, Exp 07/13
RECALLING FIRM/MANUFACTURER Pfizer Us Pharmaceutical Group, New York, NY
REASON Tablet Separation: Recalled lots may contain broken tablets.
VOLUME OF PRODUCT IN COMMERCE
138,608 bottles
DISTRIBUTION Nationwide and Puerto Rico

PRODUCT Minipress (prazosin hydrochloride) Capsules, 2 mg, 250 capsules bottle, Rx only; NDC 0069-4370-71.
CODE Lot number: V090952, Exp: 03/14; Lot number: V100373, Exp: 03/14; and Lot number: V100541, Exp: 03/14
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Pharmaceuticals LLC, Vega Baja, PR,
Manufacturer: Pfizer Pharmaceuticals LLC, Barceloneta, PR.
REASON Marketed Without an Approved NDA/ANDA: Material sourced from a manufacturer that has not been registered as a supplier for the U.S.
VOLUME OF PRODUCT IN COMMERCE 18,210 bottles
DISTRIBUTION Nationwide; Puerto Rico

PRODUCT
1) Epogen (epoetin alfa) recombinant Injection, 4000 Units/mL, 1 mL Single Use Vials (NDC 55513-148-01), packaged in 10 x 4000 Units/mL Single Use Vials per carton (NDC 55513-148-10, UPC 3 55513 14810 6); Rx only. ;

2) Epogen (epoetin alfa) recombinant Injection, 3000 Units/mL, 1 mL Single Use Vials (NDC 55513-267-01), packaged in 10 x 3000 Units/mL Single Use Vials per carton (NDC 55513-267-10, UPC 3 55513 26710 6); Rx only.

3) Epogen (epoetin alfa) recombinant Injection, 20,000 Units/2 mL (10,000 Units/mL), 2 mL Multidose Vials (NDC 55513-283-01), packaged in 10 x 2 mL Multidose Vials (NDC 55513-283-10; UPC 3 55513 28310 6); Rx only.

4) Epogen (epoetin alfa) recombinant Injection, 20,000 Units/mL, 1 mL Multidose Vials (NDC 55513-478-01), packaged in 10 x 20,000 Units/mL Multidose Vials (NDC 55513-478-10; UPC 3 55513 47810 6); Rx only.
CODE
1) Lot #: 1013869, Exp 07/12; 1016648, 1017951, Exp 12/12;

2) Lot #: 1013871, 1018223, Exp 07/12; 1020183, Exp 04/13;

3) Lot #: 1013873, 1014359, Exp 07/12; 1017475, Exp 02/13; 1018577, Exp 03/13

4) Lot #: 1015409, Exp 08/12; 1017771, 1017772, Exp 02/13; 1019054, 1019056, 1019399, Exp 04/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amgen, Inc., Thousand Oaks, CA,
Manufacturer: Amgen Manufacturing, Limited, Juncos, PR.
REASON Presence of Particulate Matter: due to the presence of glass flakes, that are extremely difficult to see, discovered in a number of vials.
VOLUME OF PRODUCT IN COMMERCE 4,484,160 vials
DISTRIBUTION Nationwide and Puerto Rico

PRODUCT Prilosec OTC (omeprazole magnesium) delayed release tablets, 20.6 mg/ acid reducer, 42 tablets, three 14-day courses of treatment, NDC: 37000-455-04. CODE
Lot Code: 01186429M1, Exp date: 12/12; Lot Code: 01176429M1, Exp date: 12/12; Lot Code: 01436429M1, Exp date: 12/12; Lot Code: 01436429N1, Exp date: 12/12; Lot Code: 01476429M1, Exp date: 12/12; Lot Code: 01476429M4, Exp date: 12/12; Lot Code: 01476429M3, Exp date: 12/12; Lot Code: 01176429W1, Exp date: 12/12; Lot Code: 01476429M2, Exp date: 12/12; Lot Code: 01166429M1, Exp date: 12/12; Lot Code: 01176429M1, Exp date: 12/12; Lot Code: 01166429W1, Exp date: 12/12; Lot Code: 01166429M2, Exp date: 12/12; Lot Code: 01176429N1, Exp date: 12/12; Lot Code: 01276429M1, Exp date: 12/12; Lot Code: 01276429N1, Exp date: 12/12; Lot Code: 01466429M1, Exp date: 12/12; Lot Code: 01476429M1, Exp date: 12/12; Lot Code: 01676429M1, Exp date: 01/13; Lot Code: 02246429M1, Exp date: 04/13; Lot Code: 01676429M1, Exp date: 01/13; Lot Code: 02296429M1, Exp date: 04/12; Lot Code: 02266429N1, Exp date: 04/13; Lot Code: 02356429N1, Exp date: 04/13; Lot Code: 01476429N1, Exp date: 12/12; Lot Code: 01166429V1, Exp date: 12/12; Lot Code: 01176429V1, Exp date: 12/12; Lot Code: 01676429V1, Exp date: 01/13; Lot Code: 01946429V1, Exp date: 03/13; Lot Code: 02306429V1, Exp date: 04/13; Lot Code: 01166429N1, Exp date: 12/12; Lot Code: 02266429N2, Exp date: 04/13; Lot Code: 02266429M1, Exp date: 04/13; Lot Code: 02296429N1, Exp date: 04/13; Lot Code: 01946429N1, Exp date: 03/13; Lot Code: 02376429N1, Exp date: 04/13; Lot Code: 01676429N1, Exp date: 01/13; Lot Code: 01676429M1, Exp date: 01/13; Lot Code: 01946429M1, Exp date: 03/13; Lot Code: 02296429M1, Exp date: 04/13; Lot Code: 02306429N1, Exp date: 04/13; Lot Code: 01166429A1, Exp date: 12/12; Lot Code: 01166429M2, Exp date: 12/12; Lot Code: 01166429W1, Exp date: 12/12; Lot Code: 01176429A1, Exp date: 12/12; Lot Code: 01176429N1, Exp date: 12/12; Lot Code: 02246429M1, Exp date: 04/13; Lot Code: 02306429N1, Exp date: 04/13; Lot Code: 01476429N1, Exp date: 12/12; Lot Code: 01486429N1, Exp date: 12/12; Lot Code: 03366429M1, Exp date: 08/13; Lot Code: 03366429N1, Exp date: 08/13; Lot Code: 03376429M1, Exp date: 08/13; Lot Code: 03376429N2, Exp date: 08/13; Lot Code: 03516429N1, Exp date: 08/13; Lot Code: 03376429N1, Exp date: 08/13; Lot Code: 03376429N2, Exp date: 08/13; Lot Code: 01476429M1, Exp date: 12/12; Lot Code: 01676429M1, Exp date: 01/13; Lot Code: 01686429M1, Exp date: 01/13; Lot Code: 01186429N1, Exp date: 12/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Procter & Gamble Co., Mason, OH,
Manufacturer: AstraZeneca, Sodertalje, Sweden.
REASON Labeling: Incorrect/Missing Lot No.(s): External package is missing or contains illegible lot code and expiration date.
VOLUME OF PRODUCT IN COMMERCE 1,602,252/42-count cartons
DISTRIBUTION Nationwide

PRODUCT
1) Ifosfamide Injection, 1 g/20 mL (50 mg/mL), 20 mL Single Dose Vial, Rx only; NDC 0703-3427-11.

2) Ifosfamide Injection, 3 g/60 mL (50 mg/mL), 60 mL Single Dose Vial, Rx only; NDC 0703-3429-11.

3) Ifosfamide Injection, 1 g/20 mL (50 mg/mL) Single Dose Vial (NDC 0703-3407-79) 10 x 20 mL vials and Mesna Injection, 1 g/10 mL (100 mg/mL) Multiple Dose Vial (NDC 0703-4805-03) 10 x 10 mL vials in each kit carton (NDC 0703-4100-58), Rx only.

4) Ifosfamide Injection, 3 g/60 mL (50 mg/mL) Single Dose Vial (NDC 0703-3409-79) 2 x 60 mL vials and Mesna Injection, 1 g/10 mL (100 mg/ml) Multiple Dose Vial (NDC 0703-4805-03) 6 x 10 mL vials in each kit carton (NDC 0703-4100-68), Rx only.
CODE
1) Lot #: 31307334B, Exp 11/10; 31308422B, Exp 02/11; and 31311307B, Exp 09/11;

2) Lot #: 31307458B, Exp 11/10; 31308419B, Exp 02/11; 31309497B, Exp 05/11; and 31310544B, Exp 06/11;

3) Lot #: 31309016C, Exp 03/11;

4) Lot #: 31307674C, Exp 02/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA.
REASON Impurities/Degradation Products: impurity level above specification at expiry.
VOLUME OF PRODUCT IN COMMERCE 78,232 vials and kits
DISTRIBUTION Nationwide

PRODUCT
1) Denti-Care, Denti-Foam, Bubble gum, 2.72% Topical Sodium Fluoride Foam (1.23% Fluoride Ions); 4.4 oz/ 125g, Rx only, Product Code: 10037-BGUN; NDC: 64778-0373-1.

2) Denti-Care, Denti-Foam, 2.72% Topical Sodium Fluoride Foam (1.23% Fluoride Ions); 4.4 oz/ 125g, Rx only, Orange; NDC: 64778-0377-1. Product Code: 10037-OUN.

3) Denti-Care, Denti-Foam, 2.72% Topical Sodium Fluoride Foam (1.23% Fluoride Ions)}; 4.4 oz/ 125g, Rx only, Mint; NDC: 64778-0376-1. Product Code: 10037-MUN.

4) Denti-Care, Denti-Foam, 2.72% Topical Sodium Fluoride Foam (1.23% Fluoride Ions)}; 4.4 oz/ 125g, Rx only, Strawberry; NDC: 64778-0379-1. Product Code: 10037-STUN.

5) Denti-Care, Denti-Foam, 2.72% Topical Sodium Fluoride Foam (1.23% Fluoride Ions)}; 4.4 oz/ 125g, Rx only, Raspberry; NDC: 64778-0378-1. Product Code: 10037-RBUN.

6) Denti-Care, Denti-Foam, 2.72% Topical Sodium Fluoride Foam (1.23% Fluoride Ions)}; 4.4 oz/ 125g, Rx only, Grape; NDC: 64778-0375-1. Product Code: 10037-GRUN.
CODE
1) Lot numbers: 30170, Exp date: 03/11; Lot number: 30788, Exp date: 05/11; Lot number: 31825, Exp date: 09/11; Lot number: 32445, Exp date: 12/11; Lot number: 32981, Exp date: 02/12; Lot number: 33311, Exp date: 03/12; and Lot number: 33540, Exp date: 04/12;

2) Lot numbers: 30169, Exp date: 03/11; Lot number: 30789, Exp date: 05/11; Lot number: 32446, Exp date: 12/11; Lot number: 32998, Exp date: 02/12; Lot number: 33537, Exp date: 04/12; Lot number: 33321, Exp date: 05/12; and Lot number: 34204, Exp date: 05/12;

3) Lot number: 30172, Exp date: 03/11; Lot number: 30837, Exp date: 04/11; Lot number: 31359, Exp date: 07/11; Lot number: 31826, Exp date: 09/11; Lot number: 32447, Exp date: 12/11; Lot number: 32983, Exp date: 02/12; Lot number: 33313, Exp date: 03/12; Lot number: 33541, Exp date: 04/12; and Lot number: 34203, Exp date: 05/12;

4) Lot numbers: 30173, Exp date: 03/11; Lot number: 30791, Exp date: 05/11; Lot number: 31360, Exp date: 07/11; Lot number: 31827, Exp date: 09/11; Lot number: 32448, Exp date: 12/11; Lot number: 32999, Exp date: 02/12; Lot number: 33322, Exp date: 03/12; Lot number: 33542, Exp date: 04/12; and Lot number: 34205, Exp date: 05/12;

5) Lot numbers: 30792, Exp date: 05/11; Lot number: 32449, Exp date: 12/11; Lot number: 33539, Exp date: 04/12, and Lot number: 34206, Exp date: 05/12;

6) Lot number: 30171, Exp date: 3/11; Lot number: 31828, Exp date: 09/11; Lot number: 32535, Exp date: 12/11; Lot number: 33000, Exp date: 02/12; Lot number: 33312, Exp date: 03/12; Lot number: 33538, Exp date: 04/12; and Lot number: 34202, Exp date: 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: A R Medicom, Augusta, GA,
Manufacturer: Medical Products Laboratories, Inc., Philadelphia, PA.
REASON Subpotent (Multiple Ingredient Drug): Over time, the fluoride ion assay may drop slightly below acceptable limits.
VOLUME OF PRODUCT IN COMMERCE 28,618 units
DISTRIBUTION Nationwide, Canada and Hong Kong

PRODUCT SSD AF*, 1% SILVER SULFADIAZINE CREAM, * Alternate Formula, 50 gram jar, Rx only, NDC 49884-601-36.
CODE Lot 26247, Exp. 03/2012 
RECALLING FIRM/MANUFACTURER Dr. Reddy's Laboratories Louisiana LLC, Shreveport, LA,
REASON Superpotent (Single Ingredient Drug): Above specification for assay at 18 months stability time point.
VOLUME OF PRODUCT IN COMMERCE 29,264 jars
DISTRIBUTION Nationwide

PRODUCT Advil (Ibuprofen) 200 mg Tablets, OTC, Pain Reliever/Fever Reducer (NSAID), 200 count bottle, NDC: 0573-0154-75.
CODE Lot number: D63757, Exp. Date: 12/1
RECALLING FIRM/MANUFACTURER Pfizer Consumer Healthcare, Guayama, PR, .
REASON Superpotent: Out of specification result on the assay (label strength) value due to overweight tablets.
VOLUME OF PRODUCT IN COMMERCE 142,056 bottles
DISTRIBUTION Nationwide and PR