Drug 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
D-1528-2016
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 75225
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,316 bottles (1,316,000 tablets)
- Official record key
drug-enforcement:D-1528-2016
Official wording
Reason: 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.
Code information: Lot # M35953S; Exp. 11/17 (labeled).
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing