JUNE 2010

WEEK ENDING JUNE 26

P&G Recalls 4 Hour Decongestant Nasal Spray 

The Procter & Gamble Company is recalling its 4-Hour Decongestant Nasal Spray. The product was distributed nationwide in the United States.

The company said it is taking this step after finding that the product formulation may not meet the expiration dates on the package. 

P&G is removing the product in question from store shelves. Consumers who have product with the UPC codes listed below and marked with an expiration date prior to June 2013 should simply discard the affected product. For further information on the product being recalled or to request a replacement coupon or refund call P&G toll-free at 877-340-8853 (Hours of operation: Monday - Friday, 9AM - 6PM US ET, Saturday, 10AM – 3PM US ET).

The product name is: VapoSpray 4 Hour Nasal Spray by Sinex with a UPC code of 3 23900 00082 7. Prior to June 2009, this product was also sold as Sinex Nasal Spray in both a spray (UPC Code 3 23900 00082 7) and Ultra Fine Mist package (UPC Code 3 23900 00085 8).

REASON Impurities/Degradation Products: Product does not meet impurity specifications.

DISTRIBUTION Nationwide

PRODUCT Ultram ER (tramadol HCl) Extended-Release Tablets, 100 mg, a) 30 count bottle, NDC 0062-0653-30, b) Physician samples 4 count blister pack, NDC 0062-0653-01, Rx only. 

REASON Does Not Meet Sustained Release Specifications: Certain lot numbers may release the active ingredient at a slightly faster rate than required by the products release specification at the 8 hour and 10 hour time points.

PRODUCT Ketotifen Ophthalmic Solution Eye Drops, 5 mL (0.17 FL OZ) Bottle, Sterile, OTC. The product was distributed under the following labels: (1) equate brand: Eye Itch Relief Drops, NDC 49035-299-12; (2) Target brand: eye drops itch relief, NDC 11673-299-12; (3) Walgreens brand: Eye Itch Relief; NDC 0363-299-12; (4) Premier Value brand: Eye Itch RELIEF DROPS, NDC 59726-299-12; (5) DISCOUNT drug mart brand: EYE ITCH Relief Drops, NDC 59726-299-12; (6) Kroger brand: EYE ITCH Relief Drops, NDC 30142-299-12; (7) AMERICAN FARE brand: EYE ITCH RELIEF DROPS, NDC 59726-299-12; (8) GOOD NEIGHBOR PHARMACY brand, NDC 24385-0494-64; (9) Equaline brand: eye itch relief, NDC 59726-299-12; (10) RITE-AID brand: Antihistamine Eye Drops; (11) GOODSENSE brand: Allergy Itchy Eye Relief Drops, NDC 59726-012-17; (12) TopCare brand: Eye Itch, NDC 59726-299-12; (13) CAREONE brand: EYE ITCH Relief Drops, Made in Canada; (14) H-E-B brand: Eye Itch RELIEF DROPS, NDC 59726-299-12; (15) CVS brand: EYE ITCH RELIEF, NDC 59726-299-12. 

REASON Failed PH Specifications: out of specification (OOS) results for pH during stability testing.

PRODUCT Red Yeast Rice 0.4%, powder in 25kg cardboard drum. 

CODE All production lots and codes sold during the period of 1/2008 to 1/2010

REASON Product contains an unapproved new drug, marketed without an NDA/ANDA (contains higher than naturally occurring amounts of Lovastatin).

VOLUME OF PRODUCT IN COMMERCE 5700 Kg

REASON Superpotent (Single Ingredient Drug): Samples had 116.7g and 118.8g which resulted in an excess dosage 218% of label claim and 222% of label claim.

PRODUCT Nifediac CC (Nifedipine) Extended Release Tables, 60 mg 100 count bottle, Rx only, NDC 0093-1022-01. 

CODE Lot #’s: 0804T28 exp 4/2010 and 0807T25 exp 5/2010

REASON Dose Not Meet Sustained Release Specifications: Active ingredient may release slightly faster than required by product release rate specification.

PRODUCT Compressed Medical Oxygen USP in A, C, D and E steel cylinders, Rx only. Each cylinder is identified with four labels which read in part: 1) "***OXYGEN, COMPRESSED U.S.P. ***UN 1072***For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, RX only. 2) "***Property Of SOS Sound Oxygen Service*** Please call for pick up if equipment needs service***". 3) The third label is an individual bar code that is a unique identifier for each cylinder "***SOS C Tank***C1283***". 4) The fourth label is a small grocery-type sticker with the lot number and expiration date of that cylinder "***10111012110 LOT #***". 

REASON CGMP Deviations: Lack of documentation that prefill, fill and/or post-fill testing of cylinders and finished products was performed.

DISTRIBUTION WA

PRODUCT Paroxetine Tablets, USP, 40 mg, 30-count bottles, Rx only; NDC 65862-157-30. 

DISTRIBUTION Nationwide

CODE

1) Lot number: 150937;

REASON Failed USP Content Uniformity Requirements: Drug was out of specification for redispersibility at the 12 month time point.

PRODUCT Tretinoin Cream, 0.025% Tretinoin topical cream, 20 gram tubes Rx only, NDC 4580218202. 

RECALLING FIRM/MANUFACTURER Recalling Firm: L. Perrigo Co., Allegan, MI, 

REASON Labeling: Label Error on Declared Strength: Tretinoin Cream 0.025% was packaged in tubes labeled as Tretinoin Cream 0.1%.

PRODUCT Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion), 118mL (4 fl oz) Bottle, Rx only; NDC 51672-1346-8. 

REASON Labeling: Label w/Wrong or Incorrect EXP. Date: The product is mislabeled with an incorrect (extended) expiration period of 24 months.

Nationwide

REASON Aveva Drug Delivery Systems, Inc., FL is recalling multiple lots of Nicotine Transdermal System that could be subpotent or have myosmine and beta-nicotyrine impurities above the 0.50% specification limit.

DISTRIBUTION NY, MI, Canada

PRODUCT Lorazepam Tablets, USP, 0.5 mg, 100 Tablets Bottle, Rx only, NDC 0781-1403-01. 

CODE Lot Number: 177265

REASON Impurities/Degradation Products: The product exceeds the Related Compound C degradant specification prior to expiry.

VOLUME OF PRODUCT IN COMMERCE 39,650 bottles

PRODUCT Quixin (levofloxacin) 0.5%, Sterile Topical Ophthalmic solution, 5 mL, Bottle-Dropper, Rx Only, NDC 68669-135-05. 

REASON Impurities/Degradation Products: out of specification levofloxacin-N-oxide (NOXO), a degradant of levofloxacin, stability test results was 0.59% at the 36 months stability (Specification limit is 0.5%).

WEEK ENDING JUNE 19

PRODUCT 
1) Tylenol Extra Strength Caplets (acetaminophen) 500 mg, a) 24 count bottle (NDC 50580-449-05, UPC #300450449054); b) 24+12 count bottle (NDC 50580-449-31, UPC #300450444318); c) 50 count bottle (NDC 50580-449-07, UPC #300450449078); d) 50 count bottle (NDC 50580-451-50, UPC #350580451502); e) 50+25 count bottle (NDC50580-449-75, UPC #300450444752); f) 100 count bottle (NDC 50580-449-09, UPC #300450449092); g) 100+25 count bottle (NDC 50580-49-00, UPC #300450449009); h) 150 count bottle (NDC 50580-449-23, UPC #300450449238); i) 150+50 count bottle (NDC 50580-449-46, UPC 300450449467); j) 225 count bottle (NDC 50580-449-27, UPC #300450444271); k) 325 count bottle (NDC 50580-449-32, UPC #300450444325). 

2) Tylenol Extra Strength Cool Caplets, (acetaminophen), 500 mg, a) 50 count bottle (NDC 50580-710-50, UPC #300450444509); b) 100 count bottle (NDC 50580-710-10, UPC #300450444103). 

3) Tylenol Extra Strength EZ Tabs, (acetaminophen), 500 mg each, a) 24 count bottle (NDC 50580-422-24, UPC #300450422248); b) 50 count bottle (NDC 50580-422-50, UPC #300450422507); c) 50+25 count bottle (NDC 50580-422-75, UPC #300450422750). 

4) Tylenol Extra Strength Rapid Release Gels (acetaminophen) 500 mg, a) 24 count bottles (NDC 50580-488-24, UPC #300450488244); b) 50 count bottles (NDC 50580-488-50, UPC #300450488503); c) 100+20 count bottles (NDC 50580-488-20, UPC #300450488176); d) 150 count bottles (NDC 50580-488-15, UPC #300450488152); e) 290 count bottles (NASCAR NDC 50580-488-29, UPC #300450488299); f) 290 count bottles (NDC 50580-488-29, UPC #300450488213). 

5) Tylenol Extra Strength Tablets, (acetaminophen), 500 mg each, Crushable, Dye Free, 60 count, NDC 50580-499-68, UPC #300450499684. 

6) Tylenol Caplets (acetaminophen), 325 mg each, 50 count bottles, (NDC 50580-501-50, UPC #350580501504), NSN 6505-01-017-1625 - For Hospital and Government Use Only. 

7) Tylenol Regular Strength Tablets (acetaminophen), 325 mg, 100 count bottle (NDC 50580-496-60, UPC #300450496607). 

8) Tylenol 8HR Extended Release Caplets, (acetaminophen), 650 mg each, Capsule-Shaped Bi-Layer Tablets, a) 24 count (NDC 50580-297-24, UPC 300450297266); b) 100 count bottles (NDC 50580-297-10, UPC #300450297112).

9) Tylenol 8 Hour Extended Release Caplets, (acetaminophen), 650 mg each, 24 count bottles, NDC 50580-297-24, UPC #300450297242, Capsule Shaped Tablets. 

10) Tylenol Arthritis Pain Extended Release Caplets, (acetaminophen), 650 mg each, 2) 50 count bottles (NDC 50580-112-50, UPC #300450838506); b) 150 count bottles (NDC 50580-112-15, UPC #300450838155); c) 225 count bottles (NDC 50580-112-37, UPC #300450838377); d) 290 count bottles (NDC 50580-112-29, UPC #300450838292). 

11) Tylenol PM Extra Strength Caplets (acetaminophen 500 mg and diphenhydramine HCl 25 mg), a) 24 count bottles (NDC 50580-482-24, UPC #300450482242); b) 24+12 count bottles (NDC 50580-482-31, UPC #300450482310); c) 50 count bottles (NDC 50580-482-50, UPC #300450482501); d) 100 count bottles (NDC 50580-482-10, UPC #300450482105); e) 100+20 count bottles, (NDC 50580-482-13, UPC #300450482136); f) 150 count (NDC 50580-482-15, UPC #300450482150); g) 225 count bottles (NDC 50580-482-35, UPC #300450482358). 

12) Tylenol PM Extra Strength Geltabs, (acetaminophen 500 mg and diphenhydramine HCl 25 mg), a) 24 count bottles, (NDC 50580-176-24, UPC #300450176240); b) 50 count bottles, (NDC 50580-176-50, UPC #300450176509); and c) 50+20 count bottles (NDC 50580-176-70, UPC #300450176707). 

13) Tylenol PM Extra Strength Rapid Release Gelcaps (acetaminophen 500 mg and diphenhydramine HCl 25 mg), a) 20 count bottles (NDC 50580-244-20, UPC #300450244208); b) 40 count bottles (NDC 50580-244-40, UPC #300450244406). 

14) Children's Tylenol Meltaways, (acetaminophen) 80 mg, 30 count bottles, Bubblegum Burst flavor, NDC 50580-519-30, UPC #300450519306. 

15) Children's Tylenol Meltaways, (acetaminophen), 80 mg, 30 count bottles, Grape flavor. 

16) Tylenol Day & Night Value Pack contains Tylenol Extra Strength Caplets (acetaminophen 500 mg) 50 count bottle and Tylenol PM Caplets (acetaminophen 500 mg and diphenhydramine HCl 25 mg) 24 count bottle, (NDC 50580-527-10, UPC #300450527103). 

17) Tylenol Arthritis Pain Extended Release Geltabs, (acetaminophen), 650 mg, a) 20 count bottles (NDC 50580-292-20, UPC #300450292209); b) 40 count bottles (NDC 50580-292-40, UPC #300450292407); and c) 80 count bottles (NDC 50580-292-80, UPC #300450292803). 
CODE
1) Lots: a) AAA408, ABA169, ABA568, ADA192, AHA048, and AJA145; b) ABA565, AHA040, and AJA028; c) AJA021, AFA176, AFA325, AHA072, and AEA206; d) 24862, 24881, 24901, 24970, 25994, 26054, 26213, 26305, 26356, 26377, 26515, and 26541; e) ACA599, and ACA755; f) AMA008, SSA013, and SSA150; g) SDA203, and SHA035; h) AAA419, SPA007, and SEA199; i) SFA071; j) SSA011; k) SPA005, SPA058, SFA295, 09BMC018,09CMC048, 09FMC082, 09FMC084, AAA405,ADA014, ADA087,ADA270, ADA271,ADA417, AEA348, AFA102, AJA045, ALA028, SFA179, SFA237, SFA295, SHA002, SJA025, SJA189, SJA232, SLA004, SLA160, SLA296, SMA173, SMA174, SSA055, SPA038, and SPA386;

2) Lots: a) ABA029, ACA563, ADA190, AHA081, AJA095 and AJA175; b) ALA249;

3) Lots: a) ABA154, ADA193, AFA243 and AHA039; b) ADA013, AEA259, AHA091, AJA010 and AJA123; c) ACA562, ACA743 and ALA173;

4) Lots: a) ABA020, ABA371, ADA280, and AHA082; b) ACA451, AEA061, AEA244, AFA103, AFA240, AHA046, AGA080, AJA040, and AJA041; c) ALA253, and AMA015; d) ASA015; e) (NASCAR) SEA191, SEA192, SFA025, SFA026, SFA136, SLA052, and SLA198; f) 09AMC008, AAA049, AAA360, ADA022, ADA178, ADA272, ADA482, AEA194, AFA010, AFA292, AHA035, AHA089, AJA167, ALA095, ALA096, SFA296, SHA039, SHA234, SLA270, SMA236, SPA037, SPA357, SSA019, SSA030, and SSA054;

5) Lot AEA243;

6) Lots: 24777, Exp 10/31/2010; 24900, Exp 12/31/2010; 24971, Exp 03/31/2011; 25971, Exp 06/30/2011; 26019, Exp 07/31/2011; 26133, Exp 09/30/2011; 26271, Exp 01/31/2012; 26422, Exp 03/31/2012; 26482, Exp 03/31/2012; and 26521, Exp 07/31/2012;

7) Lots: ABA148, Exp 10/31/2012; ABA266, Exp 10/31/2012; ABA373, Exp 11/30/2012; ACA432, Exp 01/31/2013; AFA101, Exp 04/30/2013; AHA070, Exp 05/31/2013; AJA009, Exp 06/30/2013; ALA099, Exp 05/31/2013; and AMA018, Exp 07/31/2013;

8) Lots: a) ASM379, Exp 09/30/2012; AMM322, Exp 12/31/2011; ALM325, Exp 06/30/2012; AEM105, Exp 04/30/2012; AEM087, Exp 04/30/2012; ADM031, Exp 02/29/2012; and ACM056, Exp 02/28/2012; and b) ACM037, Exp 01/31/2012; AFM351, Exp 04/30/2012; AHM316, Exp 05/31/2012; AHM376, Exp 06/30/2012; AHM422, Exp 06/30/2012; ALM388, Exp 06/30/2012; ALM458, Exp 06/30/2012; AMM368, Exp 09/30/2012; and AMM435, Exp 09/30/2012;

9) Lot: ADM032, Exp 12/31/2011;

10) Lots: a) 08KMC123, Exp 08/31/2011; and 09DMC066, Exp 01/31/2012; b) 09GMC101, Exp 04/30/2012; 09XMC114, Exp 07/31/2012; 09XMC116, Exp 05/31/2012; ASA065, Exp 09/30/2012; and ASA304, Exp 10/31/2012; c) 07BMC009, Exp 12/31/2009; 07EMC027, Exp 02/28/2010; 09EMC073, Exp 02/28/2012; 09HMC108, Exp 02/29/2012; ASA088, Exp 07/31/2012; ASA119, Exp 09/30/2012; and ASA293, Exp 07/31/2012; d) AEA180, Exp 02/28/2011; AHA076, Exp 04/30/2012; AHA077, Exp 04/30/2012; AJA019, Exp 06/30/2012; AJA116, Exp 05/31/2012; AJA117, Exp 05/31/2012; ALA029, Exp 06/30/2012; AMA025, Exp 07/31/2012; AMA270, Exp 08/31/2012; APA011, Exp 09/30/2012; APA214, Exp 09/30/2012; and APA266, Exp 10/31/2012;

11) Lots: a) AJA026, Exp 06/30/2011; ABA021, Exp 11/30/2010; ABA368, Exp 11/30/2010; and AJA025, Exp 11/31/2011; b) AJA027, Exp 05/31/2011; c) AFA005, Exp 04/30/2011; AFA280, Exp 03/31/2011; AFA289, Exp 04/30/2011; and AFA357, Exp 03/31/2011; d) AJA174, Exp 06/30/2011; and ALA250, Exp 08/31/2011; e) ALA251, Exp 08/31/2011; f) SEA188, Exp 01/31/2010; g) ABA415, Exp 11/30/2010; ACA033, Exp 12/31/2010; ACA440, Exp 12/31/2010; ACA441, Exp 12/31/2010; ADA179, Exp 02/28/2011; ADA418, Exp 02/28/2011; AEA073, Exp 03/31/2011; AFA278, Exp 04/30/2011; AFA319, Exp 04/30/2011; AHA067, Exp 04/30/2011; AJA181, Exp 06/30/2011; ALA255, Exp 08/31/2011; AMA053, Exp 08/31/2011; AMA176, Exp 08/31/2011; AMA349, Exp 09/30/2011; APA010, Exp 09/30/2011; APA216, Exp 10/31/2011; SFA084, Exp 04/30/2011; SHA044, Exp 04/30/2011; SHA157, Exp 05/31/2011; SHA230, Exp 05/31/2011; SJA026, Exp 05/31/2011; SLA050, Exp 07/31/2011; SLA272, Exp 07/31/2011; SMA081, Exp 07/31/2011; and SSA158, Exp 09/30/2010;

12) Lots: a) ABA001, Exp 11/30/2010; ABA370, Exp 11/30/2010; AFA310, Exp 05/31/2011; AHA083, Exp 05/31/2011; and AJA051, Exp 05/31/2011; b) AFA177 Exp 05/31/2011; and AFA326, 05/31/2011; c) AJA098, Exp 05/31/2011;

13) Lot: a) ABA002, Exp 11/30/2010; ABA265, Exp 11/30/2010; ADA281, Exp 02/28/2011; and AFA327, Exp 03/31/2011; b) ACA422, Exp 12/31/2010; AEA077, Exp 3/31/2011; AEA258, Exp 3/31/2011; AFA059, Exp 4/30/2011; AFA192, Exp 12/31/2010; AHA172, Exp 3/31/2011;

14) Lots: AHA069, Exp 04/30/2011 and SPA022, Exp 08/31/2010;

15) Lots: AHA023, Exp 03/31/2011 and AHA057, Exp 03/31/2011;

16) Lot: AFC005;

17) Lots: a) 09BMC031, Exp 12/31/2011; b) 08KMC130, Exp 08/31/2011 and 09BMC024 Exp 09/30/2011; c) ALM345, Exp 08/31/2012; APM305, Exp 9/30/2012; APM419, Exp 10/31/2012; ASM357, Exp 07/31/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, 
Manufacturer: Mcneil Healthcare, LLC, Las Piedras, PR. 
REASON Chemical Contamination; presence of a chemical called 2,4,6-tribromoanisole.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide, Canada, Uruguay, Fiji, Dominican Republic, Trinidad, Guatemala, Jamaica, Guam, and UAE

PRODUCT Dolonox Compressed Medical Gas Mixture (50% Nitrous Oxide USP and 50% Oxygen USP) contained in a Size E steel compressed medical gas cylinder (2015 psig). 
CODE
1) Serial number 309787C, Lot Number: N/A, No Exp. Date; 2) Serial Number ME14551, Lot Number: N/A, No Exp. Date; 3) Serial Number CCC0937914, Lot Number: N/A, No Exp. Date; 4) Serial Number 158050C, Lot Number: N/A, No Exp. Date
RECALLING FIRM/MANUFACTURER
Nitrox, Inc., Lynnwood, WA, 
REASON Marketed without an approved NDA/ANDA. The firm manufactured and distributed a compressed medical gas mixture. In addition, one cylinder lacked the labeling which identifies the gas contents as Dolonox as well as the directions for safe handling. The product was also manufactured with proper CGMP's in place.
VOLUME OF PRODUCT IN COMMERCE
Four size E steel cylinders, containing approximately 1400 psi of Dolonox
DISTRIBUTION WA

PRODUCT 
1) Oxcarbazepine tablets, 150 mg, 100 count bottles, Rx Only; NDC 68462-137-01. Batch numbers 02100198 and 02100199, Expiration 12/2011; 02100473, 01011474 and 02100481. 

2) Oxcarbazepine tablets, 300 mg, 100 count bottles, Rx Only; NDC 68462-138-01. Batch numbers 02100065, 02100084, 02100089, 02100109, 02100119, 02100141. 
CODE
1) Expiration 1/2012;
2) Expiration 12/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Glenmark Pharmaceuticals Inc., Mahwah, NJ, 
Manufacturer: Glenmark Generics Ltd., Covale-Bardex, India. .
REASON Incorrect or Missing Package Insert: a typographical error was found in the "How Supplied" section of the package outsert, showing the wrong imprint description for 150mg, 300mg and 600mg tabs.
VOLUME OF PRODUCT IN COMMERCE
90840 x 100 count bottles
DISTRIBUTION Nationwide

Mcneil Consumer Healthcare Recalls Four Product Lots of Benadryl® Allergy Ultratab™ Tablets, 100 Count, and One Product Lot of Extra Strength Tylenol® Rapid Release Gels, 50 Count 

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling the following:  Four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico  

The recall was initiated as a result of consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). 

Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Requests for reimbursement can be made at www.mcneilproductrecall.com. 

FULL RECALLED PRODUCT LIST:

WEEK ENDING JUNE 12

PRODUCT Sulfamethoxazole and Trimethoprim Injection, USP, 80mg/16 mg/mL, Vials, Rx Only, NDC # 0703-9514-01 single vials; NDC # 0703-9514-03 pkg. of 10 vials. 
CODE
Lot number: 31308526B, Exp. Date: 9/2012
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA, Inc., Sellersville, PA,
REASON Lack of Assurance of Sterility: Defective/loose crimps.
VOLUME OF PRODUCT IN COMMERCE 54000 Vials
DISTRIBUTION Nationwide

PRODUCT Glycopyrrolate Tablets, USP, 2mg, 100 tablets (10 x 10) Carton, Rx Only; NDC 68084-232-01. CODE
Lot #096785 Exp. Date 06/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, 
Manufacturer: Rising Pharmaceuticals, Inc., Allendale, NJ. 
REASON Impurities/Degradation Products: Some lots of Glycopyrrolate 2 mg tablets have the potential to exceed specifications for Impurity-I content over the shelf life of the product.
VOLUME OF PRODUCT IN COMMERCE 74 cartons
DISTRIBUTION Nationwide

PRODUCT 
1) Daytrana (Methylphenidate Transdermal System), 10 mg (1.1 mg/hr), 30 count cartons, Rx only, NDC# 54092-552-30. 

2) Daytrana (Methylphenidate Transdermal System), 15 mg (1. 6 mg/hr), 30 count cartons, Rx only, NDC# 54092-553-30. 

3) Daytrana (Methylphenidate Transdermal System), 20 mg (2. 2 mg/hr), 30 count cartons, Rx only, NDC # 54092-554-30. 

4) Daytrana (Methylphenidate Transdermal System), 30 mg (3. 3 mg/hr), 30 count cartons, Rx only, NDC # 54092-555-30. 
CODE
1) Lot # 33985, Expiration Date Jan-2011; Lot # 34167, Expiration Date Jan-2011; Lot # 2994211, Expiration Date Mar-2010; Lot #3014711, Mar-2010; Lot #3014811, Expiration Date May-2010;

2) Lot # 33986, Expiration Date Dec-2010; Lot # 34168, Expiration Date Dec-2010, Lot #38127, Expiration Date Aug-2011; Lot #38697, Expiration Date Aug-2011;

3) Lot # 33989, Expiration Date Dec-2010; Lot # 34173, Expiration Date Dec-2010; Lot # 37611, Expiration Date Apri-2011; Lot #37686, Expiration Date May-2011; Lot# 37743, Expiration Date July-2011; Lot # 38126, Expiration Date Jul-2011; Lot #38700, Expiration Date Aug-2011; Lot #39098, Expiration Date Aug-2011; Lot #2819711, Expiration Date Jan-2010;

4) Lot #33040, Expiration Date Nov-2010; Lot #33047, Expiration Date Nov-2010; Lot #33209, Expiration Date Nov-2010; Lot #33210, Expiration Date Nov-2010; Lot #33993, Expiration Date Dec-2010; Lot # 33995, Expiration DateDec-2010; Lot #34178, Expiration Date Dec-2010; Lot #34191, Expiration Date Apri-2011; Lot #37788, Expiration Date Apri-2010; Lot #3073611, Expiration Date May-2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shire PLC, Wayne, PA, 
Manufacturer: Noven Pharmaceuticals, Inc., Miami, FL. 
REASON Miscalibrated and/ or Defective Delivery System no longer meets the release liner removal specification.
VOLUME OF PRODUCT IN COMMERCE 182431
DISTRIBUTION Nationwide

PRODUCT 
1) EMBEDA (morphine sulfate and naltrexone hydrochloride, 20 mg/0.8 mg), Extended Release Capsules, 100 count bottle, Rx only; NDC 60793-430-01. 

2) EMBEDA (morphine sulfate and naltrexone hydrochloride, 30 mg/1.2 mg), Extended Release Capsules, 100 count bottle, Rx only; NDC 60793-431-01. 

3) EMBEDA (morphine sulfate and naltrexone hydrochloride, 60 mg/2.4 mg), Extended Release Capsules, 100 count bottle, Rx only; NDC 60793-434-01. 

4) EMBEDA (morphine sulfate and naltrexone hydrochloride), 50 mg/2.0 mg, Extended Release Capsules, 100 count bottle, Rx only; NDC 60793-433-01.

5) EMBEDA (morphine sulfate and naltrexone hydrochloride), 80 mg/3.2 mg, Extended Release Capsules, 100 count bottle, Rx only; NDC 60793-435-01. 

6) EMBEDA (morphine sulfate and naltrexone hydrochloride), 100 mg/4 mg, Extended Release Capsules, 100 count bottle, Rx only; NDC 60793-437-01.
CODE
1) Lots 581H91, 158G91 and 582H91, Exp. 07/2011;
2) Lots 159G91 and 585H91, Exp. 07/2011;
3) Lots 616H91, 503H91 and 617H91, Exp. 07/2011;
4) Lots 160G91, 586H91 and 587H91, Exp. 07/2011;
5) Lot 583H91, Exp. 07/2011;
6) Lot 588H91, Exp. 07/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals Inc., Bristol, TN,  
Manufacturer: Actavis Elizabeth LLC, Elizabeth, NJ. REASON Failed dissolution testing for Morphine Sulfate during stability testing.
VOLUME OF PRODUCT IN COMMERCE
44,184 bottles
DISTRIBUTION Nationwide

WEEK ENDING JUNE 5

Pfizer Initiates a  Recall of All Lots of Metronidazole Injection, Ciprofloxacin Injection, and Ondansetron Injection Bags Made by Claris Lifesciences Due to Non-Sterility

Pfizer Inc is recalling Metronidazole, Ciprofloxacin and Ondansetron IV Products due to the presence of floating matter and non-sterility discovered by the manufacturer Claris Laboratories. Non-sterility of a product administered via the intravenous route has the potential to result in infections.

All lots of the following products are affected by this recall:

• Metronidazole injection USP 500 mg/100 ml flexible IV plastic container (NDC 0069-2390-01);  

• Ciprofloxacin in Dextrose (5%) injection, USP 200 mg / 100 mL flexible plastic container for IV infusion (NDC 0069-4395-19);

• Ciprofloxacin in Dextrose (5%) injection, USP 400 mg / 200 mL flexible plastic container for IV infusion (NDC 0069-4396-27); and 

• Ondansetron in 5% Dextrose injection 32 mg / 50 mL flexible plastic container (NDC 0069-0700-12).  

Customers should immediately quarantine, discontinue distribution of and return all recalled lots of these products, as well as notify any of their customers to whom they distributed the products. 

For information about returning recalled products distributed under the “Pfizer Injectables” label, contact Stericycle Inc. at 1-800-805-3093. Any adverse events that may be related to the use of these products should be reported to Pfizer at 1-800-438-1985 at any time, 24 hours a day.  

West-Ward Pharmaceuticals Recalls Ondansetron in 5% Dextrose Injection And Metronidazole Injection, USP Bags 

West-Ward Pharmaceuticals Inc., of Eatontown, NJ, is  recalling all lots of Claris LifeSciences Inc. manufactured Ondansetron in 5% Dextrose Injection, supplied in 32mg/50mL Single-Use Plastic Bag Containers and Metronidazole Injection 500mg/100ml USP in Flexible IV Plastic Bag Containers. Claris recently received reports of the presence of floating matter and non-sterility in Ondansetron and Metronidazole. 

Customers should immediately quarantine, discontinue distribution and return all recalled lots of these products, as well as notify any of their customers to whom the recalled products were distributed. West-Ward is notifying all direct wholesalers and customers of the recall by letter, and asking each to notify those who purchased the recalled product to immediately return all remaining inventory. To date, the firm has not received any confirmed reports of adverse events or complaints of reduced effectiveness associated with the recalled lots. 

Healthcare providers and patients can contact West-Ward customer service if they have questions about the recall. 

West-Ward customer service may be reached at 1-800-631-2174, Monday thru Friday 8:00am EST to 4:45pm EST.  

Sagent Pharmaceuticals Initiates a Recall of All Lots of Ondansetron in 5% Dextrose Injection, 32 mg/50 mL Manufactured by Claris Lifesciences 

Sagent Pharmaceuticals, Inc. is recalling all lots of ondansetron injection in 5% dextrose 32mg / 50 mL (NDC number 25021-776-50) manufactured by Claris Lifesciences and distributed by Sagent. The lot numbers being recalled are: A090309, A090310, A090311 and A090312, which were distributed to hospitals, wholesalers and distributors nationwide from August 2009 through May 2010. Ondansetron injection is an intravenous product used to treat nausea and vomiting associated with chemotherapy or surgery and is supplied in a single dose plastic container.

Sagent has initiated this recall due to the discovery of foreign material and non-sterility in one lot of ondansetron injection. 

Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.SagentPharma.com. 

Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about ondansetron injection may contact Sagent Medical Affairs (866-625-1618 option 3).

PRODUCT Semprex-D Capsules (8 mg acrivastine/60 mg pseudoephedrine hydrochloride), 100 Capsule bottles, Rx only; NDC 53014-404-10. 
CODE
Lots A43528, A43529, Exp. 10/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: UCB Manufacturing, Inc., Rochester, NY, 
Manufacturer: DSM Pharmaceuticals Inc., Greenville, NC. 
REASON Impurities/Degradation products.
VOLUME OF PRODUCT IN COMMERCE
36762 units (100 count bottles)
DISTRIBUTION Nationwide

PRODUCT 
1) Concentrated Tylenol Infants' Drops, (Acetaminophen), 80 mg, a) 1/2 oz Bottle Dropper (UPC 300450122155 and UPC 350580144183), b) 1 oz Bottle Dropper (UPC 300450122018 and UPC Code 300450122100), OTC, Grape Flavor. 

2) Concentrated Tylenol Infants' Drops (Acetaminophen), 80 mg, 1 oz Bottle Dropper, OTC, Dye Free, Cherry Flavor, UPC 300450167118 and 300450167019. 

3) Concentrated Tylenol Infants' Drops(Acetaminophen), 80 mg, a)1/2 oz Bottle Dropper (UPC 300450186157); b) 1 oz Bottle Dropper (UPC 300450186300), OTC, Cherry Flavor. 

4) Concentrated Motrin Infants' Drops (Ibuprofen), 50 mg, a) 1/2 oz Bottle Dropper (UPC 300450198150), b) 1 oz Bottle Dropper (UPC 300450198013 and UPC 300450198112), OTC, Dye-Free, Original Berry Flavor. 

5) Concentrated Motrin Infants' Drops, (Ibuprofen), 50 mg, 1/2 OZ Bottle Dropper, OTC, Original Berry Flavor, UPC 300450524157. 

6) Children's Zyrtec Allergy, (Cetirizine HCl) Allergy, 1 mg, Syrup 1/2 oz Bottle, OTC, Bubble Gum, UPC Code 300450205155. 

7) Johnson's Baby Relief Kit, OTC, which contains Concentrated Tylenol Infants Drops, 1/2 oz Bottle Dropper, Grape and Concentrated Motrin Infants Drops 1/2 oz Bottle Dropper, Berry, UPC Code 381370026426. 
CODE
1) Lot numbers: a) AAM004, AAM021, ABM030, SDM124, SEM051, SFM027, SHM018, SJM130, SLM105, SMM059, SMM072, SMM152, and SSM040, and AAM062, SDM123, SJM131, SMM005, SPM008, SSM003, and SSM034; b) AAM099, SEM099, SFM003, SJM088, SMM009, SMM082, SSM019, SSM080; and  SDM079, SDM080, SDM081, SDM100, SDM101, SEM047, SJM015, SJM089 and SJM162;

2) Lot numbers: SDM097, SDM129, SDM130, SDM131, SEM046, SHM042, SHM061, SJM057, SJM157, and SMM008; and AAM005, AAM085, AAM120, SDM128, SEM098, SFM004, SFM005, SFM006, SHM024, SHM041, SJM087, SJM189, SLM038, SLM039, SLM110, SLM111, SLM112, SMM068, SMM083, SPM038, SPM065, and SSM018;

3) Lot numbers: a) AAM093, SDM093, SEM050, SEM113, SHM032, SJM049, SLM052, SLM104, SMM043, SMM073, SPM009, SPM059, and SSM061; b) SJM137, SLM113, and SPM039;

4) Lot numbers: a) SCM079, SEM072, SJM081, SMM004, SMM166, and SSM072, b) SDM010, SDM011, SDM037, SDM132, SEM048, SEM079, SEM080, SEM101, SEM120, SEM121, SEM122, SEM123, SHM033, SJM056, SJM090, SLM058, SLM059, SLM060, SMM010, SMM011, SMM066, SMM067, SSM048, SSM067; and  SDM098, SDM099, SEM049, SEM100, SFM007, SFM008, SFM009, SHM062, SJM055, and SJM158;

5) Lot numbers: AAM118, AAM119, SDM031, SDM069, SDM092, SEM071, SJM007, SLM053, SMM003, SMM044, SMM167, SSM012, and SSM062;

6) Lot numbers: SMM153, SPC019, SPC022, SPC023, SPM010, and SPM010A;

7) Lot numbers: 2058J, 2748J, 2808J, 2818J, 3088J, 3098J, 3438J, 3458J, 0129J, 0149J, 0709J, 0719J, 0729J, 0759J, 0969J, 0979J, 0989J, 2059J, 2089J, 2109J, 2119J, and 2449J
RECALLING FIRM/MANUFACTURER
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA,
REASON
Labeling: Incorrect/Missing Lot No.(s): There is a potential for the product lot number and/or expiration date to become illegible on the bottle label.
VOLUME OF PRODUCT IN COMMERCE
18,707,407 bottles, droppers and 66,560 kits
DISTRIBUTION Nationwide; Dominican Republic , Trinidad & Tobago, Guatemala, Jamaica, Maite, UAE, and Kuwait

Claris Lifesciences  recalls all lots of Ciprofloxacin Inj. USP 200 mg / 100 mL, Ciprofloxacin Inj. USP 400 mg / 200 mL, Metronidazole Inj. USP 500 mg/100 ml and Ondansetron Inj., 32 mg / 50 mL. 

Claris Lifesciences is recalling all lots of Ciprofloxacin Inj. USP 200 mg / 100 mL (NDC 36000-008-24), Ciprofloxacin Inj. USP 400 mg / 200 mL (NDC 36000-009-24), Metronidazole Inj. USP 500 mg/100 ml (NDC 36000-001-24), and Ondansetron in 5% Dextrose Inj. 32 mg / 50 mL (36000-014-06) manufactured and distributed by Claris Lifesciences. All lots are being recalled, which were distributed to hospitals, wholesalers and distributors nationwide.

Claris is recalling the products listed above because it has received reports of floating matter which may pose risk if administered to patients. Healthcare professionals should NOT use these products, and should immediately remove them from their pharmacy inventories.

Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at http://www.clarislifesciences.com/Claris_USA/index.asp¹. Any questions about returning unused product should be directed to the customer call center at +1 (877) 725- 2747, M-F 8am-7pm CST.