Recalls / Class II
Class IID-0268-2019
Product
Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854, Made in the USA.
- Affected lot / code info
- 69367-120-01 Irbesartan 150mg Tablets, 30 count bottle B161005A Sep-19 C161002A Feb-20 69367-120-03 Irbesartan 150mg Tablets, 90 count bottle B161005B Sep-19 C161002B Feb-20
Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Recalling firm
- Firm
- Sciegen Pharmaceuticals Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 89 Arkay Dr, N/A, Hauppauge, New York 11788-3727
Distribution
- Quantity
- 5,061 HDPE bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-10-29
- FDA classified
- 2018-11-20
- Posted by FDA
- 2018-11-28
- Terminated
- 2023-09-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0268-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.