JUNE 2012

WEEK ENDING JUNE 30

Standard Process Issues Recall of Three Supplements 

Standard Process Inc. of Palmyra, WI 53156 is recalling the following three dietary supplements due to potential Salmonella contamination:

The products, all tablets, were distributed in 60 cc and 200 cc amber glass bottles with Best Used By dates (BUB) of 5/13 indicated on both the bottles and the boxes. No other products or lot numbers are affected.

The products were sold to consumers through health care professionals.

Consumers who have purchased any of these three products with specific lot codes of L114 are urged to return it to the place of purchase for a full refund. Consumers and health care professionals with questions can contact Standard Process Inc. at 866-397-3237.

Bedford Laboratories Issues Recall Of Vecuronium Bromide For Injection Preservative Free, Lot 2067134

Bedford Laboratories today announced a recall for:

          Vecuronium Bromide for Injection, 20 mg vial – NDC #55390-039-10
          Lot 2067134 – Exp. Date 5/31/2013
          First Shipment – 8/8/2011
          Last Shipment – 11/9/2011

Please note: This recall is for lot 2067134 only. No other lots of Vecuronium Bromide for injection Preservative Free are subject to this voluntary recall.

This recall is being conducted due to the discovery of particulate matter in a small number of vials within the lot listed above. Particulate matter has been recognized as a potential health hazard. 

Healthcare practitioners who had received the lot were instructed not to use the product and immediately quarantine it for return. Anyone with questions can contact Bedford Laboratories Client Services at 800-562-4797 between 8 a.m. and 5 p.m. Eastern time, Monday through Friday.

Product Type

Recalling Firm

Classification

Status

Distribution Pattern

Event Details

Drugs

Physicians Total Care, Inc

Class I

Completed

FL

Details

Drugs

Teva Pharmaceuticals USA, Inc.

Class III

Ongoing

Nationwide

Details

Drugs

Abbott Laboratories

Class II

Ongoing

Nationwide

Details

Drugs

Linde Gas LLC

Class II

Ongoing

Distributed only within Ohio. No Federal Government, foreign or Canadian consignees received product.

Details

Drugs

Kutol Products Co Inc

Class II

Ongoing

IL

Details

Drugs

Hospira, Inc.

Class III

Ongoing

Nationwide

Details

Drugs

Physicians Total Care, Inc.

Class II

Completed

AK, NC, GA

Details

 

WEEK ENDING JUNE 23

Product Type

Recalling Firm

Classification

Status

Distribution Pattern

Event Details

Drugs

Luitpold Pharmaceuticals, Inc.

Class II

Ongoing

Nationwide, Puerto Rico, and Abu Dhabi

Details

Drugs

Quadrant Chemical Corporation

Class III

Ongoing

Maine

Details

Drugs

Endo Pharmaceuticals, Inc.

Class III

Ongoing

Nationwide and Puerto Rico

Details

Drugs

Ben Venue Laboratories Inc

Class II

Ongoing

Nationwide and Puerto Rico.

Details

Drugs

Noven Pharmaceuticals, Inc.

Class II

Ongoing

Nationwide and Puerto Rico.

Details

Drugs

Airgas Inc

Class II

Ongoing

Medical facilities in AZ and CA.

Details

Drugs

Bausch & Lomb, Inc.

Class II

Ongoing

Nationwide

Details

Drugs

Hospira, Inc.

Class II

Ongoing

Nationwide.

Details

Drugs

Meridian Medical Technologies a Pfizer Company

Class II

Ongoing

Nationwide, Italy, Singapore, Sweden, and Canada.

Details

Drugs

Physicians Total Care, Inc.

Class II

Completed

NC and KY

Details

 

WEEK ENDING JUNE 16

RECALLS PENDING 
PRODUCT Metoprolol Tartrate Tabets USP 50mg, Rx only, 1000-count bottle, NDC 0093-0733-10
CODE Lot # TE1Y261, Exp 12/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Sellerville, PA
Manufacturer: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India
REASON FOR RECALL Tablet Thickness: Product is being recalled due to some tablets not conforming to weight specifications. 
 
PRODUCT Zeosa(TM) (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable), 75 mg), Rx only, 28 day regimen, Carton (NDC 0093-2090-58) containing three (3) individual blister packs (NDC 0093-2090-28),
CODE Lot #'s 33800226A, Exp 7/2012; 33800333A, Exp 10/2012; 33800870A, Exp 10/2012; 33802533A, Exp 4/2013; and 33802720A, Exp 8/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Sellerville, PA 18960
Manufacturer: Teva Women’s Health, Cincinnati, OH 45213
REASON FOR RECALL Impurities/degradation products: Product is being recalled due to the potential for some lots not meeting impurity specifications.
 
RECALLS 
PRODUCT Atenolol Tablets USP, 25 mg, a) 100 count bottle (NDC 0093-0787-01), b) 1000 count bottle (NDC 0093-0787-10), Rx only. 
CODE Lot #'s: a) 90A024, 90A026, Exp 09/13; b) 90A028, Exp 09/13
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,
Manufacturer: Teva Pharmaceutical Industries Ltd., Jerusalem, Israel. 
REASON                                                                                                                                                
Presence of Foreign Substance(s): This recall is being carried out due to the potential presence of stainless steel particulates in the tablets.
VOLUME OF PRODUCT IN COMMERCE 78,682 bottles
DISTRIBUTION Nationwide

 

PRODUCT Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only; NSN 6505-01-274-0951, NDC 11704-600-01.
CODE Lot # 8D1082, Exp 01/13; 8D1151, Exp 03/13
RECALLING FIRM/MANUFACTURER Meridian Medical Technologies a Pfizer, Co, Saint Louis, MO, 
REASON Impurities/Degradation Products: High out of Specification levels for carbostyril, a known degradation product of diazepam.
VOLUME OF PRODUCT IN COMMERCE 83,701 autoinjectors
DISTRIBUTION Nationwide, Italy, Singapore, Sweden, and Canada

 

PRODUCT Murocel (methylcellulose) Lubricant Ophthalmic Solution (USP, 1%), 15 mL bottle, OTC, NDC 24208-280-15. 
CODE Lot # 467061, 487551, 507521, 548051, 132171, 136571, 140181
RECALLING FIRM/MANUFACTURER Bausch & Lomb, Inc., Tampa, FL, 
REASON Lack of Assurance of Sterility: Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point.
VOLUME OF PRODUCT IN COMMERCE 59,777 bottles
DISTRIBUTION Nationwide
 
PRODUCT Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, NDC 0781-5248-92, UPC 3 0781-5248-92 5.
CODE Lot #: BJ3186, BJ3142, Exp 12/12.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz Inc., Broomfield, CO, 
Manufacturer: Sandoz Private Limited, Navi Mumbai, Maharashtra, India. 
REASON                                                                                                                                                 
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
VOLUME OF PRODUCT IN COMMERCE 7,545 bottles
DISTRIBUTION Nationwide and PR

 

PRODUCT Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in a 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, NDC 0781-5584-36.      
CODE
Lot #: LF00478C, LF00479C, Exp 10/12; LF00551C, LF00552C, Exp 01/13; LF00687C, LF00688C, Exp 04/13; LF00763C, LF00764C, LF00765C, Exp 06/13; LF01261C, Exp 03/14
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Broomfield, CO, 
Manufacturer: Laboratorios Leon Farma SA, Leon, Spain. 
REASON                                                                                                                                                 
Contraceptive Tablets Out of Sequence: Patient complaint that inactive tablets were found in row 9 of a blister card instead of the appropriate row 13.
VOLUME OF PRODUCT IN COMMERCE 31,858 unit cartons
DISTRIBUTION Nationwide

WEEK ENDING JUNE 9

PRODUCT HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged 10-count Carpujects per carton, NDC 0409-1283-31
CODE Lot #07547LL, Exp 07/01/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL
Manufacturer: Hospira Inc., McPherson, KS
REASON FOR RECALL Superpotent (Single Ingredient) Drug: The prefilled cartridge units have the potential to be overfilled and may contain more than the 1 mL labeled fill volume.
 
PRODUCT Alprazolam Extended-release Tablets, USP, 2mg, 60 count bottle, Rx Only, NDC 0378-5023-91. 
CODE Lot No. 3029082
RECALLING FIRM/MANUFACTURER Mylan Pharmaceuticals Inc., Morgantown, WV,
REASON Failed USP Dissolution Test Requirements: Routine stability testing for Alprazolam XR tablets yielded out of specification dissolution results.
VOLUME OF PRODUCT IN COMMERCE 20,921 bottles
DISTRIBUTION Nationwide
 
PRODUCT Duragesic 25 mcg/h (Fentanyl Transdermal System), One (25 mcg/h) System (patch), CII, Rx only, NDC 50458-091-05. 
CODE Lot 1103836P1; Exp, 03/2013
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Ortho-McNeil-Janssen Pharmaceuticals, Inc., Titusville, NJ, 
Manufacturer: Alza Corp., Vacaville, CA.  
REASON                                                                                                                                                
Crystallization: One lot of Duragesic 25 mcg/h (fentanyl transdermal system) exhibited white spots, which were determined to be small fentanyl crystals.
VOLUME OF PRODUCT IN COMMERCE 53, 640 patches
DISTRIBUTION Nationwide

 

PRODUCT
1) Methylin Chewable Tablets (methylphenidate HCl) 2.5 mg, 100 count bottle, Rx only, NDC 59630-760-10. 
 
2) Methylin Chewable Tablets (methylphenidate HCl) 5 mg, 100 count bottle, Rx only NDC 59630-761-10. 
 
3) Methylin Chewable Tablets (methylphenidate HCl) 10 mg, 100 count bottle, Rx only, NDC 59630-762-10. 
CODE
1) Lot # AMT21102A;
2) Lot # AMT51101A; AMT51102A;
3) Lot # AMTIOI lOlA; AMTIOII02A
RECALLING FIRM/MANUFACTURER Mallinckrodt Inc., Hobart, NY, 
REASON Stability Data does not Support Expiration Date: Covidien Mallinckrodt Inc. is conducting a voluntary recall of Methylin Chewable Tablets because of failed stability testing.
VOLUME OF PRODUCT IN COMMERCE 7,380 100-ct bottles
DISTRIBUTION Nationwide

 

PRODUCT
1) Ropinirole Hydrochloride Tablets, 3 mg, 500 tablets per Bottle, Rx only, NDC 60429-797-05. 
 
2) Ropinirole Hydrochloride Tablets, 4 mg, 500 tablets per Bottle, Rx only, NDC 60429-798-05. 
 
3) Ropinirole Hydrochloride Tablets, 5 mg, 500 tablets per Bottle, Rx only, NDC 60429-799-05. 
CODE
1) Lot # 102797A, Exp. 11/11; 103538A, 103538B, 103538C, Exp 01/12;
2) Lot # 103255A, 103255B, Exp.12/11;
3) Lot # 102799A, 102799B, 102799C, 102799D, Exp 11/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Golden State Medical Supply Inc., Camarillo, CA, 
Manufacturer: Corepharma LLC, Middlesex, NJ. 
REASON                                                                                                                                                
Labeling: Incorrect or Missing Package Insert. Recall due to discrepancy with package outsert.
VOLUME OF PRODUCT IN COMMERCE 148 bottles
DISTRIBUTION Nationwide

Sandoz US Announces Recall Of Oral Contraceptive Introvale®

Sandoz is conducting a recall of 10 lots of its generic oral contraceptive Introvale® in the US, following a recent report of a packaging flaw. 

The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the US between January 2011 and May 2012.

The recall was decided after a consumer reported that the white placebo tablets were mistakenly in the ninth row (labeled "Week 9") of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled "Week 13"). 

In the unlikely event that a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception. They should also immediately contact their healthcare professional as well as Sandoz to report the finding via the Sandoz Drug Information Direct Line at 800-525-2492, 24 hours/day, seven days a week, or via email at qa.druginfo@sandoz.com.

Botanical Laboratories Inc. Recalls Wellesse Digestive 3 in 1 Health® 

Botanical Laboratories of Ferndale, WA is recalling 38 bottles of 33.8 oz "Digestive 3 in 1 Health " liquid dietary supplement and 275 bottles of 16 oz. "Digestive Health 3 in 1" liquid dietary supplement, because a supplier of one of the ingredients has indicated the ingredient has the potential to be contaminated with Salmonella.

Botanical Laboratories is recalling the following: 16 oz. size has "LOT 34441C (followed by a four digit time code)A EXP 03/2014" jet coded on the bottom of the bottle.  The 33.8 oz. size has "LOT 34552C (followed by a four digit time code)A EXP 03/2014" jet coded on the bottom of the bottle.   Both "Digestive 3 in 1 Health" 16 oz. and 33.8 oz. products are packaged in white HDPE plastic bottles with a full body shrink sleeve label.  The label is predominantly orange with green trim and print. The brand Wellesse appears across a white band at the top of the bottle in blue print.  The product name "Digestive 3 in 1 Health" is printed on the front of the label in white with green trimmed print. 

Both 33.8 oz. and 16 oz "Digestive 3 in 1 Health" were distributed nationwide through retail stores, and online retailers. The product was distributed after 05/01/2012.

Consumers who have purchased Wellesse "Digestive 3 in 1 Health" with one of the above referenced lot numbers are urged to return it to the place of purchase for a full refund.  Consumers with questions may contact the company at 1-800-232-4005.

WEEK ENDING JUNE 2

PRODUCT Kold Sore Spray with liquid sea mineral, 1 fl oz bottle.
CODE All lots.
RECALLING FIRM/MANUFACTURER Wholistic Herbs, Inc., Dallas, TX,
REASON Non-Sterility: This product is intended for use in the eye and was manufactured under non sterile conditions.
VOLUME OF PRODUCT IN COMMERCE 313 bottles
DISTRIBUTION Nationwide
 
PRODUCT Koff & Kold Spray (huang liam, lugol iodine, quercetin), 1 fl oz bottles.
CODE All lots.
RECALLING FIRM/MANUFACTURER Wholistic Herbs, Inc., Dallas, TX
REASON CGMP Deviations: This product was manufactured in a manner that lacks good manufacturing practices.
VOLUME OF PRODUCT IN COMMERCE 973 bottles
DISTRIBUTION Nationwide