notyard
04-14-2009, 12:53 PM
FDA class II recall:
PRODUCT
Granisetron Hydrochloride Injection 1mg/mL For I.V. Use Only, Contains no Preservatives. Rx only, NDC number for individual vials is 0703-7871-01. NDC number for packages containing 10 vials is 0703-7871-03, Recall # D-168-2009
CODE
Lot number: 31300740B exp 2/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on October 24, 2008.
Manufacturer: Teva Parenteral Medicines, Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
Exceeds pH Specifications
VOLUME OF PRODUCT IN COMMERCE
8,430 vials
DISTRIBUTION
Nationwide
PRODUCT
Granisetron Hydrochloride Injection 1mg/mL For I.V. Use Only, Contains no Preservatives. Rx only, NDC number for individual vials is 0703-7871-01. NDC number for packages containing 10 vials is 0703-7871-03, Recall # D-168-2009
CODE
Lot number: 31300740B exp 2/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on October 24, 2008.
Manufacturer: Teva Parenteral Medicines, Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
Exceeds pH Specifications
VOLUME OF PRODUCT IN COMMERCE
8,430 vials
DISTRIBUTION
Nationwide