The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0271-2019·Announced 2018-11-28

Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 150 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a 'Severe' rating under the rubric, particularly given the presence of a known carcinogenic impurity (NDEA) in a prescription medication.

Plain-English summary

Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, USP, 150 mg, in 30-count and 90-count bottles. The recall involves 18,760 HDPE bottles distributed nationwide. The product is marketed by GSMS Incorporated and manufactured by ScieGen Pharmaceuticals, Inc.

The recall was initiated because FDA laboratory testing confirmed the presence of an impurity, N-nitrosodimethylamine (NDEA), in the product. This is a Class II recall, indicating a situation in which there is a reasonable probability that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Patients and consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments. The specific lot numbers and expiration dates affected are listed in the recall documentation.

The recalled product

Product
GSMS 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 ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
Manufacturer
Sciegen Pharmaceuticals Inc
Category
Drug — Prescription Medication
Hazard
Affected units
18,760

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)

  • 60429-641-90 Irbesartan 150mg Tablets
  • 30 Count Bottle GS019526 Nov-19 GS020252 Nov-19 GS020958 Nov-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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