The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1044-2019·Announced 2019-03-27

AvKARE Recalls Losartan Potassium Tablets Due to Impurity

AvKARE Inc. is recalling Losartan Potassium Tablets 50 mg because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.

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 severity score under the rubric for drug recalls involving impurities.

Plain-English summary

AvKARE Inc. is recalling Losartan Potassium Tablets USP 50 mg, 50 Tablets (5x10) Unit Dose boxes (NDC 50268-517-15). The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the presence of an impurity identified as N-Methylnitrosobutyric acid (NMBA).

The affected lots are 20961 (Expiration 09/2019) and 20477 (Expiration 08/2019). The product was distributed nationwide.

Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
Manufacturer
AVKARE 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)

  • Lots: 20961 Exp. 09/2019
  • 20477 Exp. 08/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by AVKARE 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 3 products in this recall →

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