IRBESARTAN Tablets recall: Impurity Out of Spec
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: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
Why was IRBESARTAN Tablets recalled?
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (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?
Lot Numbers: 30-count bottles GS019036; Exp 09/19 GS019073; Exp. 09/19 GS021472; Exp. 11/19 GS021530; Exp. 11/19 GS022234; Exp. 02/20 90-count bottles B162009; Exp. 09/19 B162010; Exp. 09/19 B162011; Exp. 09/19 B162012; Exp. 11/19 B162013; Exp. 11/19 B162014; Exp. 11/19 B162015; Exp. 11/19 C162001; Exp. 02/20
- Product
- 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: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
- Recalling firm
- Golden State Medical Supply Inc.
- Quantity
- 12,502 bottles
- Distribution
- Product was distributed throughout the United States.
- Recall date
- November 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)