notyard
08-16-2009, 12:29 AM
FDA class III recall:
PRODUCT
Rising Potassium Citrate Extended-Release Tablets, USP 10 mEq (1080 mg per tablet), Rx only, 100 Tablets, NDC 64980-138-01, Recall # D-1880-2009
CODE
Lot CPF846, Exp: June 2010
RECALLING FIRM/MANUFACTURER
Corepharma LLC, Middle***, NJ, by letter on June 30, 2009. Firm initiated recall is ongoing.
REASON
Failed Dissolution Specification; 9 months stability
VOLUME OF PRODUCT IN COMMERCE
3502 bottles of 100
DISTRIBUTION
NJ
PRODUCT
Rising Potassium Citrate Extended-Release Tablets, USP 10 mEq (1080 mg per tablet), Rx only, 100 Tablets, NDC 64980-138-01, Recall # D-1880-2009
CODE
Lot CPF846, Exp: June 2010
RECALLING FIRM/MANUFACTURER
Corepharma LLC, Middle***, NJ, by letter on June 30, 2009. Firm initiated recall is ongoing.
REASON
Failed Dissolution Specification; 9 months stability
VOLUME OF PRODUCT IN COMMERCE
3502 bottles of 100
DISTRIBUTION
NJ