The Recall Desk
SevereFDA (Drugs)·D-0270-2019·Announced 2018-11-28

Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 75 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 and involves the confirmed presence of NDEA, a known carcinogenic impurity, which meets the criteria for a Severe rating due to significant health risk potential.

Plain-English summary

Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottles (NDC 60429-640-90). The recall involves 3,835 HDPE bottles distributed nationwide. The product is marketed by GSMS Incorporated and manufactured by ScieGen Pharmaceuticals, Inc.

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. The affected lots are identified by codes B160003 and B160004, both with a September 2019 expiration date.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recall is classified as Class II by the FDA.

The recalled product

Product
GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
Manufacturer
Sciegen Pharmaceuticals Inc
Category
Drug — Prescription Medication
Hazard
Affected units
3,835

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 (2)

  • 60429-640-90 Irbesartan 75mg Tablets
  • 90 Count Bottle B160003 Sep-19 B160004 Sep-19

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.

See all 6 products in this recall →

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