Food Recalls (FDA)

Bimeda Inc. on Behalf of Manufacturer Bimeda-MTC Animal Health Inc. Issues Voluntary Nationwide Recall of Sterile Solutions Due to Concerns Regarding Sterility and Possible Health Risk

Published on Thursday, 09 May 2013 21:28

FG_AUTHORS: FDA

Recall -- Firm Press Release FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. Bimeda Inc. on Behalf of Manufacturer Bimeda-MTC Animal Health Inc. Issues Voluntary Nationwide Recall of Sterile Solutions Due to
Concerns Regarding Sterility and Possible Health Risk
  Contact:
Consumer:
888-524-6332Media:
416-863-2130
866-805-9530
cnwtor@newswire.ca

FOR IMMEDIATE RELEASE - May 2, 2013 - Bimeda Inc., on behalf of the manufacturer, Bimeda-MTC Animal Health Inc. is voluntarily recalling one lot of Calcium Gluconate, one lot of Dextrose 50%, and one lot of Hypertonic Saline, all of which are in the form of injectable fluids, to the user level. These injectable fluids are being recalled as a precautionary measure; because of departures from customary sterility procedures, sterility cannot be entirely assured.

The products potentially could result in a reaction in animals administered the products listed in the table below. There have been no adverse events reported to date with respect to the above-noted products, and although no product contamination has been identified in the lots that have been tested for sterility; because of departures from our customary protocol, sterility cannot be entirely assured.

The products are used as fluid therapies and packaged in plastic serum 500 mL or 1000 mL bottles. Following are the affected lot numbers, expiration dates, and label identifiers:

Product NameProduct NumberLot NumberLabelShipment DateQuantityExpiry Date
Calcium Glucium1CAL0282J029ABimeda11/01/1220,06409/14
Dextrose 50%1DEX0052J028Bimeda10/26/12670209/15
Hypertonic Saline1HYP0092J041MWI11/01/12897509/14

These products were distributed nationwide to veterinary product wholesalers and retailers.

Bimeda Inc., on behalf of manufacturer Bimeda-MTC Animal Health Inc., is notifying its distributors and customers by press release and is arranging for return of all recalled products. Users, distributors or retailers that have any of these products should stop using the product and return to place of purchase.

Customers with questions regarding this recall can contact Bimeda Inc. by phone 888-524-6332, Option or extension #2, Monday to Friday from 9 AM to 5 PM CST. Customers should contact their veterinarian if animals owned by them have experienced any problems that may be related to using these products.

 

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