Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
Product description
PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91
Lot numbers, UPCs & expiration codes
Lot # M35953S; Exp. 11/17 (labeled).
Where it was sold
Nationwide
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-1528-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 15, 2016
- FDA report date
- Oct 5, 2016
- Quantity
- 1,316 bottles (1,316,000 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1528-2016, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 75225
- Address
- 235 East 42nd Street
- Code information
- Lot # M35953S; Exp. 11/17 (labeled).
- Postal code
- 10017-5703
- Report date
- Oct 5, 2016
- Product type
- Drugs
- Recall number
- D-1528-2016
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 1,316 bottles (1,316,000 tablets)
- Termination date
- Aug 9, 2017
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 15, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 27, 2016