The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1283-2019·Announced 2019-05-29

Losartan Potassium Tablets Recalled Due to Impurity Presence

Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 25 mg 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 above acceptable limits.

Plain-English summary

Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets USP 25 mg, 90-count bottles (NDC 60429-316-90). The recall involves 64,362 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 at the manufacturer.

Patients and healthcare providers should stop using the affected lots and contact their healthcare provider for alternative treatment. The affected lot codes are GS015172 (exp 06/2019), GS017634 (exp 02/2020), GS017653 (exp 02/2020), GS017980 (exp 02/2020), GS017276 (exp 02/2020), GS017045 (exp 02/2020), and GS016726 (exp 02/2020).

The recalled product

Product
Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
64,362

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 (6)

  • GS015172 exp 06/2019 GS017634 02/2020
  • GS017653 exp 02/2020
  • GS017980 exp 02/2020
  • GS017276 exp 02/2020
  • GS017045 exp 02/2020
  • GS016726 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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