Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity
Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, USP, 300 mg, because FDA testing confirmed the presence of 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant health risks.
Plain-English summary
Sciegen Pharmaceuticals, Inc. is recalling GSMS Irbesartan Tablets, USP, 300 mg, in 30-count and 90-count bottles. The recall involves 30,194 HDPE bottles distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of an impurity, N-nitrosodimethylamine (NDEA), in the product.
Consumers with these products should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatments. The affected NDCs are 60429-642-30 and 60429-642-90.
The recalled product
- Product
- GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
- Manufacturer
- Sciegen Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 30,194
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 (1)
- 60429-642-30 Irbesartan 300mg Tablets
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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