GSMS Irbesartan Tablets recall: Impurity Out of Spec
GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS…
Why was GSMS Irbesartan Tablets recalled?
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
60429-640-90 Irbesartan 75mg Tablets, 90 Count Bottle B160003 Sep-19 B160004 Sep-19
- Product
- GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS…
- Recalling firm
- Sciegen Pharmaceuticals Inc
- Quantity
- 3,835 HDPE bottles
- Distribution
- Nationwide
- Recall date
- November 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)