D-0300-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 19, 2018
- Initiation Date
- October 29, 2018
- Termination Date
- October 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1571 bottles
Product Description
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
Reason for Recall
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Distribution Pattern
Nationwide.
Code Information
Batch Numbers: a) B160002A Exp. 09/30/2019; b) B160002B Exp. 09/30/2019