The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0265-2019·Announced 2018-11-28

Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity

Golden State Medical Supply is recalling 12,502 bottles of Irbesartan 300 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 is a significant health hazard warranting a Severe rating under the rubric for significant injury/property-damage reports or high-risk contamination.

Plain-English summary

Golden State Medical Supply Inc. is recalling 12,502 bottles of IRBESARTAN Tablets, USP 300 mg. The affected products are available in 30-count and 90-count bottles and were distributed throughout the United States. The recall is 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 stop using the recalled medication and contact their healthcare provider for further instructions. The specific lot numbers and expiration dates for the affected 30-count and 90-count bottles are listed in the official recall documentation.

The recalled product

Product
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.
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
12,502

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 (14)

  • Lot Numbers: 30-count bottles GS019036
  • Exp 09/19 GS019073
  • Exp. 09/19 GS021472
  • Exp. 11/19 GS021530
  • Exp. 11/19 GS022234
  • Exp. 02/20 90-count bottles B162009
  • Exp. 09/19 B162010
  • Exp. 09/19 B162011
  • Exp. 09/19 B162012
  • Exp. 11/19 B162013
  • Exp. 11/19 B162014
  • Exp. 11/19 B162015
  • Exp. 11/19 C162001
  • Exp. 02/20

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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