Reported Jul 10, 2013 · Terminated
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28…
Pfizer Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pfizer Inc. · 235 East 42nd Street · New York, NY · 10017-5703
Is this the product you have?
- Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0975-11
- Lot codes and dates
- Lots
E77055E96153&
- F11111 Exp06/13
- Lots
- Amount recalled
- 135,520 blister cards
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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