The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0264-2019·Announced 2018-11-28

Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity

Golden State Medical Supply is recalling Irbesartan 150 mg tablets because FDA testing found 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 and involves the presence of a nitrosamine impurity (NDEA), which aligns with the rubric criteria for Severe severity involving significant health risks.

Plain-English summary

Golden State Medical Supply Inc. is recalling 15,917 bottles of IRBESARTAN Tablets, USP 150 mg. The affected products are 30-count and 90-count bottles distributed throughout the United States. The tablets were manufactured by SciGen Pharmaceuticals, Inc. and distributed by GSMS, Incorporated.

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. The agency has classified this recall as Class II.

Consumers should check their medication for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, patients should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
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: GSMS, Incorporated, Camarillo, CA 93012, USA.
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
15,917

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 (13)

  • Lot Numbers: 30-count bottles: GS019526
  • Exp. 11/19 GS020252
  • Exp. 11/19 GS020958
  • Exp. 11/19 Lot Numbers: 90-count bottles B161003
  • Exp. 09/19 B161004
  • Exp. 09/19 B161006
  • Exp. 09/19 B161007
  • Exp. 09/19 B161008
  • Exp. 11/19 B161009
  • Exp. 11/19 B161010
  • Exp. 11/19 C161001
  • Exp. 02/20 C161003
  • Exp. 05/20

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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