The Recall Desk
SevereFDA (Drugs)·D-1285-2019·Announced 2019-05-29

Losartan Potassium Tablets Recalled Due to Impurity Presence

Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.

What this means for you

Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences are categorized as Severe (Score 4), particularly when involving significant chemical impurities like NMBA.

Plain-English summary

Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets USP 100 mg, 90-count bottles (NDC 60429-318-90). The recall involves 138,213 HDPE bottles distributed to Illinois, Michigan, Minnesota, Pennsylvania, Tennessee, and Texas, as well as two U.S. government and one Veterans Affairs account.

The recall was initiated because FDA laboratories confirmed the presence of the impurity N-Methylnitrosobutyric acid (NMBA) in the finished product. The levels of this impurity were found to be above the interim acceptable daily intake level at the manufacturer. This is classified as a Class II recall, indicating a situation where use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences.

Patients and healthcare providers should stop using the affected lots and contact their healthcare provider for a replacement. The affected lots are identified by specific lot codes and expiration dates ranging from June 2019 to February 2020, including GS014045, GS014305, GS014044, GS016535, GS016524, GS017384, GS017385, GS017539, GS017540, GS017543, GS017542, GS017984, GS017985, GS017986, GS018263, GS018264, and GS018265.

The recalled product

Product
Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
138,213

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 (17)

  • GS014045
  • exp 06/2019
  • GS014305 exp 06/2019
  • GS014044 exp 0/2019
  • GS016535 exp 01/2020
  • GS016524 exp 01/2020
  • GS017384 exp 02/2020
  • GS017385 exp 01/2020
  • GS017539 exp 01/2020
  • GS017540 exp 01/2020
  • GS017543 exp 01/2020
  • GS017542 exp 01/2020 GS017984 exp 02/2020
  • GS017985 exp 02/2020
  • GS017986 exp 02/2020
  • GS018263 exp 02/2020
  • GS018264 exp 02/2020
  • GS018265 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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