Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Carcinogen Impurity
Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical 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 involves a carcinogen impurity, which aligns with the rubric criterion for Severe (Score 4) involving significant injury or structural defects, though no specific injuries are reported in the text.
Plain-English summary
Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle. The recall involves 89,616 bottles distributed nationwide in the United States. The specific batches affected are BV77D013, BV77C011, BV77D001, BV77D002, BV77D003, BV77D004, BV77D005, BV77D006, BV77D007, BV77D008, BV77D009, BV77D010, BV77D011, BV77D012, BV77C009, and BV77C010.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of a carcinogen impurity in the active pharmaceutical ingredient (API) used to manufacture the drug product. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should check their inventory for the specific NDC (13668-204-30) and batch numbers listed above. If the product is found, it should be returned to the pharmacy or healthcare provider for disposal or replacement according to standard recall procedures.
The recalled product
- Product
- Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 89,616
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 (16)
- Batch: BV77D013
- BV77C011
- BV77D001
- BV77D002
- BV77D003
- BV77D004
- BV77D005
- BV77D006
- BV77D007
- BV77D008
- BV77D009
- BV77D010
- BV77D011
- BV77D012
- BV77C009
- BV77C010
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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