The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1463-2019·Announced 2019-07-17

Losartan Potassium tablets recalled due to impurity detection

Golden State Medical Supply Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.

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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury reports or structural defects are Severe; while no injuries are explicitly reported, the presence of a nitrosamine impurity in a Class II recall aligns with the Severe tier criteria for significant potential harm.

Plain-English summary

Golden State Medical Supply Inc. is recalling Losartan Potassium, 50 mg tablets, 90 count bottles (NDC 60429-317-90). The recall involves 14,955 bottles, containing a total of 1,345,950 tablets. The specific lot number is GS017651, with an expiration date of 01/2020.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an impurity known as N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was detected in the active pharmaceutical ingredient (API) used to manufacture the finished products.

The affected products were distributed to one US government account nationwide. No foreign accounts were involved. Consumers and healthcare providers should stop using the affected lot and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Medication
Hazard

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 (2)

  • Lot #: GS017651
  • Expiration 01/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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