The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1046-2019·Announced 2019-03-27

AvKARE Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets 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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant chemical impurities like NMBA.

Plain-English summary

AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg, 50 Tablets (5x10) Unit Dose boxes. The affected product is identified by Lot 19326 with an expiration date of 03/31/2019. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the presence of an impurity known as N-Methylnitrosobutyric acid (NMBA).

The affected units were distributed nationwide. This is a prescription-only medication. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Patients and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The recalling firm, AvKARE Inc., is responsible for managing the recall and notifying affected parties.

The recalled product

Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15
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 (1)

  • Lot: 19326 Exp. 03/31/2019

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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