The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1286-2019·Announced 2019-05-29

Losartan Potassium Tablets Recalled Due to Impurity Presence

Golden State Medical Supply is recalling Losartan Potassium Tablets because FDA labs found an impurity above acceptable levels.

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 nitrosamine impurity.

Plain-English summary

Golden State Medical Supply Inc. is recalling 8,767 bottles of Losartan Potassium Tablets USP 100 mg (NDC 60429-318-10). The recall involves 1,000-count HDPE bottles distributed to accounts in Illinois, Michigan, Minnesota, Pennsylvania, Tennessee, and Texas, including two U.S. government and one Veterans Affairs account.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-Methylnitrosobutyric acid (NMBA) in the finished product at levels above the interim acceptable daily intake limit.

Patients and healthcare providers should stop using the affected lots and contact their healthcare provider for alternative treatment options. The specific lot codes and expiration dates are listed in the official recall notice.

The recalled product

Product
Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
8,767

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 (12)

  • GS014054 exp 06/2019
  • GS016338 exp 12/2019
  • GS016341 exp 01/2020
  • GS016342 exp 01/2020
  • GS016343 exp 01/2020
  • GS016344 exp 01/2020
  • GS016345 exp 01/2020
  • GS016539 exp 01/2020
  • GS016969 exp 01/2020
  • GS016973 exp 01/2020
  • GS017337 exp 01/2020
  • GS018524 exp 02/2020

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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