Recalls / Class III
Class IIID-631-2013
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
- Affected lot / code info
- Lots: E77055, E96153, & F11111 Exp: 06/13
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.
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 135,520 blister cards
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-05-31
- FDA classified
- 2013-06-28
- Posted by FDA
- 2013-07-10
- Terminated
- 2017-04-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-631-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.