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.
Reported: November 28, 2018 Initiated: November 2, 2018 #D-0265-2019
Product Description
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.
Reason for Recall
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Details
- Recalling Firm
- Golden State Medical Supply Inc.
- Units Affected
- 12,502 bottles
- Distribution
- Product was distributed throughout the United States.
- Location
- Camarillo, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Golden State Medical Supply Inc.. Units affected: 12,502 bottles.
Why was this product recalled? ▼
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 28, 2018. Severity: Moderate. Recall number: D-0265-2019.
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