Recalls / Class II
Class IID-0269-2019
Product
Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), 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
- 69367-121-01 Irbesartan 300mg Tablets, 30 count bottle B162008A Sep-19 C162002A Feb-20 69367-121-03 Irbesartan 300mg Tablets, 90 count bottle B162008B Sep-19 C162002B 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
- 5,989 HDPE
- 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-0269-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.