Losartan Potassium/HCTZ Tablets Recalled for Nitrosamine Impurity
RemedyRepack is recalling Losartan Potassium/HCTZ tablets because FDA testing found a nitrosamine 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/health risk reports.
Plain-English summary
RemedyRepack, Inc. is recalling Losartan Potassium/HCTZ, 100 mg/12.5 mg tablets, 90-count bottles. The product was manufactured by Torrent Pharmaceuticals and distributed to Florida. The specific lot number is B0517068-101618 with an expiration date of 10/2019. The total quantity involved is 44 HDPE bottles, containing 3,960 tablets.
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. The detected levels of NMBA exceeded the interim acceptable daily intake level of 0.96 parts per million.
Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The product is identified by NDC 70518-1560-00.
The recalled product
- Product
- Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Antihypertensive
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 #: B0517068-101618
- Exp. Date: 10/2019
Distribution
Distributed in 1 state:
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