Premarin Tablet, Film Coated
FDA Recall NDC 0046-1104
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Premarin (NDC 0046-1104). A significant event, classified as Class III, was initiated on Sep 15, 2016 by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
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.
Sep 15, 2016
Oct 05, 2016
1,316 bottles (1,316,000 tablets)
Recall Profile & Regulatory Data
Event ID
75225
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 09, 2017
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
Batch or Lot Expiration Information
Lot# M35953S; Exp. 11/17 (labeled).
Affected Packages Involved in this Recall
0046-1101-81Product
0046-1102-81Product
0046-1102-91Product
0046-1102-52Product
0046-1104-81Product
0046-1104-91Product
0046-1100-81Product
0046-1100-91Product
0046-1100-52Product
0046-1103-81Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
