notyard
06-05-2009, 03:06 PM
FDA class II recall:
PRODUCT
Furosemide Tablets, USP, 40 mg, 1000 Tablets, Rx only, 0781-1966-10. Recall # D-423-2009
CODE
Lot number: 180974, Exp 12-11
RECALLING FIRM/MANUFACTURER
Recall Firm: Sandoz, Inc, Princeton, NJ, by letter on April 10, 2009.
Manufacturer: Sandoz Inc, Broomfield, CO. Firm initiated recall is complete.
REASON
Furosemide tablets were out of specification for tablet thickness and potency.
VOLUME OF PRODUCT IN COMMERCE
5773 / 1000 tablet bottles
DISTRIBUTION
Nationwide
PRODUCT
Furosemide Tablets, USP, 40 mg, 1000 Tablets, Rx only, 0781-1966-10. Recall # D-423-2009
CODE
Lot number: 180974, Exp 12-11
RECALLING FIRM/MANUFACTURER
Recall Firm: Sandoz, Inc, Princeton, NJ, by letter on April 10, 2009.
Manufacturer: Sandoz Inc, Broomfield, CO. Firm initiated recall is complete.
REASON
Furosemide tablets were out of specification for tablet thickness and potency.
VOLUME OF PRODUCT IN COMMERCE
5773 / 1000 tablet bottles
DISTRIBUTION
Nationwide