Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active ingredient.
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, and the detection of a carcinogen impurity in a prescription drug represents a significant health risk, meeting the criteria for a Severe rating.
Plain-English summary
Torrent Pharma Inc. is recalling Amlodipine, Valsartan, and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle. The recall involves 37,704 bottles distributed nationwide in the United States. The affected batches are BBY4D004, BBY4E001, BBY4D001, BBY4D002, and BBY4D003.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, a carcinogen impurity was detected in the active pharmaceutical ingredient (API) used to manufacture the drug product.
Consumers and healthcare providers should stop using the affected medication and contact their healthcare provider for further instructions. The product is prescription-only.
The recalled product
- Product
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 37,704
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 (5)
- Batch: BBY4D004
- BBY4E001
- BBY4D001
- BBY4D002
- BBY4D003
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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