Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets
Torrent Pharma Inc. is recalling Losartan Potassium/Hydrochlorothiazide tablets due to the presence of 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 classified this as an FDA Class II recall, and the presence of a nitrosamine impurity above acceptable levels in a prescription medication constitutes a significant health risk.
Plain-English summary
Torrent Pharma Inc. is recalling Losartan Potassium/Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle. The recall involves 17,088 bottles of the medication, identified by Lot BEF7D051. The product was distributed nationwide in the United States and Puerto Rico.
The recall was initiated because FDA laboratory testing confirmed the presence of an impurity, N-Methylnitrosobutyric acid (NMBA), in the finished product. The levels of this impurity were found to be above the interim acceptable daily intake level of 9.82 parts per million.
Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 17,088
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 BEF7D051
Distribution
Part of a larger recall action
This product is one of 4 recalled by Torrent Pharma 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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