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.

FDA recall notice · announced November 28, 2018 · Golden State Medical Supply

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.

Notes

Distribution: Product was distributed throughout the United States.
Lot/code information: 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
Quantity: 12,502 bottles
Status: Terminated
Products in this recall event:
- IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by (D-0264-2019)
- IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-9 (D-0263-2019)
- 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 (D-0265-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.