FDA recall D-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

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-09-15

Report date

2016-10-05

Termination date

2017-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1528-2016