Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 25 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 recall is classified as FDA Class II, and the presence of a nitrosamine impurity (NMBA) above acceptable levels represents a significant health risk, meeting the criteria for a Severe rating.
Plain-English summary
Heritage Pharmaceuticals, Inc. is recalling 15,541 bottles of Losartan Potassium Tablets USP 25 mg, 90 film coated tablets. The affected product is Lot CLO17006A with an expiration date of 11/2019. The tablets 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 above the interim acceptable daily intake level at the manufacturer.
Consumers should stop using the recalled product and contact their healthcare provider for further instructions. Heritage Pharmaceuticals can be reached at 1-866-901-DRUG (3784).
The recalled product
- Product
- Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage…
- Manufacturer
- Heritage Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 15,541
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 CLO17006A exp 11/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Heritage 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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