Pfizer Recalls Premarin Tablets Due to Incorrect Expiration Date Labeling
Pfizer is recalling 1,316 bottles of Premarin 1.25 mg tablets because they were labeled with an incorrect expiration date of 11/17 instead of 09/17.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error regarding the expiration date.
Plain-English summary
Pfizer Inc. is recalling 1,316 bottles of PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000-count bottles. The recall is due to a labeling error where the bottles were incorrectly marked with an expiration date of 11/17, while the correct expiration date is 09/17. The affected product is identified by Lot # M35953S and NDC 0046-1104-91.
The affected product was distributed nationwide. This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers with this product should check the expiration date and lot number on their bottles. If the expiration date is 11/17 and the lot number is M35953S, they should contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- Product
- PREMARIN (ESTROGENS, CONJUGATED)
- Brand
- PREMARIN
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # M35953S
- Exp. 11/17 (labeled).
UPCs (3)
- 0300461100913
- 0300461103815
- 0300461101811
Distribution
Distributed nationwide across the United States.
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