Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 50 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 levels constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury/property-damage reports or high-risk contamination.
Plain-English summary
Heritage Pharmaceuticals, Inc. is voluntarily recalling Losartan Potassium Tablets, USP 50 mg. The recall involves 3,012 bottles of the prescription medication, which are distributed nationwide. The affected product is manufactured by Vivimed Life Sciences Private Limited in India for Heritage Pharmaceuticals, Inc. in East Brunswick, New Jersey.
The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of an impurity, N-Methylnitrosobutyric acid (NMBA), in the finished product at levels above the interim acceptable daily intake limit at the manufacturer.
The specific lots affected are CLO17007A, CLO17008A, and CLO17009A, all with an expiration date of 11/2019. The National Drug Code (NDC) for the product is 23155-645-10. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Losartan Potassium Tablets, USP 50 mg 1000 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
- 3,012
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)
- Lot CLO17007A Lot CLO17008A Lot CLO17009A
- 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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