A.H. Robins Has Recalled Premphase Tablets (Safetyalerts) - The Food and Drug Administration FDA) released the following information.
PRODUCTa) Premphase Tablets, (conjugated estrogens 0.625mg and medroxyprogesterone 5mg) dial dispenser containing 28 tablets, Rx only. Recall # D-067-3;B) Premarin Tablets (conjugated estrogens) 0.625 mg, Rx only, unit dose packages of 100 (NDC 0046-0867-99), bottles of 100 (NDC 0046-0867-81) and bottles of 5000 (NDC 0046-0867-95). Recall # D-068-3.
CODEa) Lot 9001385, Exp 2/2003; Lot 9001386, Exp 2/2003B) Lot 9001216, Exp 5/03; Lot 9000986, Exp 5/05; Lot 9000846, Exp 5/05.
RECALLING FIRM/MANUFACTURERA.H. Robins, Richmond, VA, by letter dated 11/18/02. Firm initiated recall is ongoing.
REASONDissolution; failure to meet specifications at the 24 month/2-hour timepoint.
VOLUME OF PRODUCT IN COMMERCEa) Premphase - 41,220 unitsB) Premarin - 198,676 units.
DISTRIBUTIONNationwide.
~~~~~~~~~~~~~~~~~~~~~~~~~~
Bristol-Myers Squibb Has Recalled ESTRACE tablets (Safetyalerts) - The Food and Drug Administration (FDA) released the following information.
PRODUCTESTRACE tablets (estradiol tablets, USP), 2 mg, 100 and 500 count bottles, Rx Only. Recall # D-116-3.
CODE100 Count bottles - Lot no. 0K28404, Exp. Date Oct-2003, 500 Count bottles - Lot no. 0J41630, Exp. Date Oct-2003.
RECALLING FIRM/MANUFACTURERBristol-Myers Squibb Company, New Brunswick, NJ, by letters on November 11, 2002. Firm initiated recall is ongoing.
REASONDissolution Failure.
VOLUME OF PRODUCT IN COMMERCE4,587 bottles.
DISTRIBUTIONNationwide and Canada.