The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1465-2019·Announced 2019-07-17

Losartan Potassium Tablets Recalled Due to NMBA Impurity Detection

Golden State Medical Supply Inc. is recalling Losartan Potassium 100 mg tablets because an impurity called NMBA 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the detection of a nitrosamine impurity (NMBA) in the active pharmaceutical ingredient.

Plain-English summary

Golden State Medical Supply Inc. is recalling Losartan Potassium, 100 mg tablets, 90 count bottles (NDC 60429-318-90). The recall involves 32,835 bottles, totaling 2,955,150 tablets. The affected lots are GS017042, GS017043, GS017044, and GS017541, all 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 product was distributed to one U.S. government account nationwide. No foreign accounts were involved. Consumers and healthcare providers should check their inventory for the specific NDC and lot numbers listed above and stop using the product if it matches the recall details.

The recalled product

Product
Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90
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 (5)

  • Lot #: GS017042
  • Expiration 01/2020
  • GS017043
  • GS017044
  • GS017541

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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