Recalls / Class III
Class IIID-1528-2016
Product
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
- Brand name
- Premarin
- Generic name
- Estrogens, Conjugated
- Active ingredient
- Estrogens, Conjugated
- Route
- Oral
- NDCs
- 0046-1100, 0046-1101, 0046-1102, 0046-1104, 0046-1103
- FDA application
- NDA004782
- Affected lot / code info
- Lot # M35953S; Exp. 11/17 (labeled).
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.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 1,316 bottles (1,316,000 tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-09-15
- FDA classified
- 2016-09-27
- Posted by FDA
- 2016-10-05
- Terminated
- 2017-08-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1528-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.