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.
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
Lot numbers, UPCs & expiration codes
Lots: E77055, E96153, & F11111 Exp: 06/13
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-631-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 31, 2013
- FDA report date
- Jul 10, 2013
- Quantity
- 135,520 blister cards
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-631-2013, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 65393
- Address
- 235 East 42nd Street
- Code information
- Lots: E77055, E96153, & F11111 Exp: 06/13
- Postal code
- 10017-5703
- Report date
- Jul 10, 2013
- Product type
- Drugs
- Recall number
- D-631-2013
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 135,520 blister cards
- Termination date
- Apr 6, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- May 31, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 28, 2013