Recalls / Class II
Class IID-0302-2019
Product
Westminster Irbesartan Tablets, USP 300 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 69367-121-01; b) 90 count bottle NDC 69367-121-03
- Affected lot / code info
- Batch Numbers: a) B162008A Exp. 09/30/2019, C162002A Exp. 02/29/2020; b) B162008B Exp. 09/30/2019, C162002B Exp. 02/29/2020
Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Recalling firm
- Firm
- Westminster Pharmaceuticals Llc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 & 2, 154 Downing Street, Olive Branch, Mississippi 38654
Distribution
- Quantity
- 3976 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2018-10-29
- FDA classified
- 2018-12-14
- Posted by FDA
- 2018-12-19
- Terminated
- 2021-10-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0302-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.