RemedyRepack Recalls Amlodipine/Valsartan/HCTZ Tablets Due to NDMA Contamination
RemedyRepack Inc. is recalling Amlodipine/Valsartan/HCTZ tablets in South Carolina due to trace amounts of NDMA, a possible impurity.
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 source text explicitly states the agency classification is Class II. Per the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4. Since this is FDA Class II, it maps to the 'Severe' category (Score 4) in the provided rubric structure where Class II is grouped with Severe criteria.
Plain-English summary
RemedyRepack Inc. is recalling Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg tablets (NDC #70518-1220-0) manufactured by Torrent Pharma LTD. The recall involves 3 bottles of 90 tablets (270 tablets overall) distributed in South Carolina. The specific lot number is B0476653-080218 with an expiration date of 08/2019.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving the detection of trace amounts of NDMA, a possible impurity or contaminant, in an active pharmaceutical ingredient. The FDA has classified this recall as Class II.
Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Prescription Medication
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 (3)
- 70518-1220-0
- Lot #: B0476653-080218
- Exp. Date: 08/2019
Distribution
Distributed in 1 state:
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