Class II
Terminated
Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-119-01; b) 90 count bottle NDC 69367-119-03
- Company
- Westminster Pharmaceuticals Llc
- Recall Initiated
- October 29, 2018
- Posted
- December 19, 2018
- Recall Number
- D-0300-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1571 bottles
- Firm Location
- Olive Branch, MS, United States
Reason for Recall
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Distribution
Nationwide.
Lot / Code Info
Batch Numbers: a) B160002A Exp. 09/30/2019; b) B160002B Exp. 09/30/2019
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