Avet Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Avet Pharmaceuticals is recalling Losartan Potassium Tablets 50 mg because FDA testing 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the presence of a nitrosamine impurity above acceptable levels.
Plain-English summary
Avet Pharmaceuticals, Inc. is recalling Losartan Potassium Tablets USP 50 mg in 30, 90, and 1000-count bottles. The recall involves specific lot numbers CL018008A, CL018008B, and CL018009A, all with an expiration date of March 2020. The affected units were distributed nationwide.
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 level.
Patients and consumers who have these specific bottles of Losartan Potassium Tablets should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc.…
- 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 (4)
- a) CL018008A
- exp Mar 2020
- b) CL018008B
- c) CL018009A
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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