Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11
Reported: July 10, 2013 Initiated: May 31, 2013 #D-630-2013
Product Description
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11
Reason for Recall
Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 432,657 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/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11. Recalled by Pfizer Inc.. Units affected: 432,657 blister cards.
Why was this product recalled? ▼
Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 10, 2013. Severity: Low. Recall number: D-630-2013.
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