Avet Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Avet Pharmaceuticals is recalling Losartan Potassium Tablets 100 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 agency classification is FDA Class II, and the presence of a nitrosamine impurity (NMBA) above acceptable limits represents a significant health risk, aligning with the 'Severe' criteria for significant injury/property-damage reports or high-risk contamination.
Plain-English summary
Avet Pharmaceuticals, Inc. is recalling Losartan Potassium Tablets USP 100 mg, which are supplied in 30, 90, and 1000-count bottles. The product is prescription-only and was manufactured by Vivimed Life Sciences Private Limited in India for Heritage Pharmaceutical Inc.
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 exceeding the interim acceptable daily intake limit.
The affected lots are distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or replacements.
The recalled product
- Product
- Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage…
- Manufacturer
- Avet Pharmaceuticals, 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 (10)
- a) CL018022B
- exp Apr 2020 b) CL018010A Mar 2020
- CL018017B
- CL018018A exp Apr 2020 c) CL018011A
- CL018012A exp Mar 2020
- CL018013A
- CL018015A
- CL018016A
- CL018017A
- exp Apr 2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Avet Pharmaceuticals, 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.
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