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
Reported: July 10, 2013 Initiated: May 31, 2013 #D-631-2013
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
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.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 135,520 blister cards
- Distribution
- Nationwide and Puerto Rico
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Pfizer Inc.. Units affected: 135,520 blister cards.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 10, 2013. Severity: Low. Recall number: D-631-2013.
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