Torrent Pharma Recalls Losartan Potassium/Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling Losartan Potassium/Hydrochlorothiazide Tablets because FDA testing found an impurity above acceptable levels.
What this means for you
Illness, injury, or structural failure has been reported. 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 severity score under the rubric, particularly given the presence of a nitrosamine impurity above acceptable limits.
Plain-English summary
Torrent Pharma Inc. is recalling Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle. The recall involves 8,688 bottles of the prescription medication, identified by Lot 4P04D007 and NDC 13668-118-90. The product was distributed nationwide in the United States and Puerto Rico.
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 this impurity exceeded the interim acceptable daily intake level of 9.82 parts per million.
Consumers and healthcare providers should stop using the affected medication and contact their healthcare provider for guidance on alternative treatment options. The recalling firm is Torrent Pharma Inc., located in Basking Ridge, NJ.
The recalled product
- Product
- Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 8,688
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 4P04D007
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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