Drug product
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
D-631-2013
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 65393
- Status
- Terminated
- Classification
- Class III
- Quantity
- 135,520 blister cards
- Official record key
drug-enforcement:D-631-2013
Official wording
Reason: 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.
Code information: Lots: E77055, E96153, & F11111 Exp: 06/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications