FDAFDA · Food and drugs·Recall number D-0268-2019
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.
Published November 28, 2018 · Recall initiated: October 29, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Sciegen Pharmaceuticals Inc
- Distributor
- Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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