The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0263-2019·Announced 2018-11-28

FDA Recalls Irbesartan Tablets Due to NDEA Impurity

Golden State Medical Supply Inc. is recalling 2,439 bottles of Irbesartan 75 mg tablets because FDA testing confirmed the presence of the impurity N-nitrosodiethylamine (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' severity score under the rubric for significant injury or property damage reports, or high-risk contamination.

Plain-English summary

Golden State Medical Supply Inc. is recalling 2,439 bottles of IRBESARTAN Tablets, USP 75 mg (NDC 60429-640-90). The product was manufactured by SciGen Pharmaceuticals, Inc. and distributed by GSMS, Incorporated. The affected lots are B160003 and B160004, both with an expiration date of 09/19.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of an impurity, N-nitrosodiethylamine (NDEA), in the product. NDEA is a potential carcinogen.

The product was distributed throughout the United States. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for alternative treatment options.

The recalled product

Product
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 60429-640-90.
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
2,439

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 (3)

  • Lot Numbers: B160003
  • Exp. 09/19 B160004
  • Exp. 09/19

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Golden State Medical Supply 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 3 products in this recall →

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