Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity
Sciegen Pharmaceuticals is recalling Irbesartan Tablets, 150 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of NDEA, a probable human carcinogen, constitutes a significant health risk warranting a Severe rating under the rubric for significant injury reports or high-risk contamination.
Plain-English summary
Sciegen Pharmaceuticals Inc. is recalling Westminster Irbesartan Tablets, USP, 150 mg, in 30-count and 90-count bottles. The recall involves 5,061 HDPE bottles distributed nationwide.
The recall was initiated because FDA laboratory testing confirmed the presence of an impurity, N-nitrosodimethylamine (NDEA), in the product. This finding represents a Current Good Manufacturing Practice (CGMP) deviation.
Consumers should stop using the recalled medication and contact their healthcare provider for guidance on alternative treatment options. The affected products are identified by NDC 69367-120-01 and 69367-120-03, with specific lot codes B161005A, C161002A, B161005B, and C161002B.
The recalled product
- 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…
- Manufacturer
- Sciegen Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 5,061
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)
- 69367-120-01 Irbesartan 150mg Tablets
- 90 count bottle B161005B Sep-19 C161002B 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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