Status
Terminated
Drug Enforcement D-631-2013
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.
Classification
Class III
Report Date
July 10, 2013
Termination Date
April 6, 2017
Product Information
- Product description
- 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
- Product quantity
- 135,520 blister cards
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Pfizer Inc.
- Address
-
235 East 42nd Street, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-631-2013
- Event ID
- 65393
- Recall initiation date
- May 31, 2013
- Center classification date
- June 28, 2013
- Code info
- Lots: E77055, E96153, & F11111 Exp: 06/13
- More code info
- —