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MaryO
SafetyalertsFebruary 7, 2003

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.

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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.

zjsurfer
Seems everything can be "recalled" these days!  I don't think I'm affected--I take 1 mg. Estrace.

Thanks for the info!

Zelma

rawas
I also take 1 mg of Estrace.

Sometimes we adults have to make choices as to whether or not to take HRT.  There's no one answer.

Each of us should weigh the pros and cons and reach our own conclusion--not those of the doctor or of our friends.

There's no guarantees in life for not getting any of the diseases like breast cancer or heart attacks.

Life is a gamble and unfortunately we all have to take it.

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