Sciegen Recalls Irbesartan Tablets Due to NDEA Impurity
Sciegen Pharmaceuticals is recalling Irbesartan 300mg tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the presence of NDEA, a potential carcinogen, in a prescription drug constitutes a significant health risk warranting a Severe rating.
Plain-English summary
Sciegen Pharmaceuticals Inc. is recalling Westminster Irbesartan Tablets, USP, 300mg. The affected products are 30-count and 90-count bottles manufactured in the USA. The recall covers specific lot numbers B162008A, C162002A, B162008B, and C162002B.
The recall was initiated because FDA laboratory testing confirmed the presence of an impurity called N-nitrosodimethylamine (NDEA) in the product. This finding represents a Current Good Manufacturing Practice (CGMP) deviation.
The products were distributed nationwide. Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed in the recall notice and stop using the affected tablets.
The recalled product
- 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 t
- Manufacturer
- Sciegen Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 5,989
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 69367-121-01 Irbesartan 300mg Tablets
- 90 count bottle B162008B Sep-19 C162002B Feb-20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Sciegen Pharmaceuticals Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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