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:

• Cataplex ACP (Product number 0700 and 0750) Lot 114
• Cataplex C (Product number 1650 1655) Lot 114
• Pancreatrophin PMG (Product number 6650) Lot 114

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.

WEEK ENDING JUNE 23

WEEK ENDING JUNE 16

WEEK ENDING JUNE 9

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