The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1146-2018·Announced 2018-09-05

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.

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 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
Hazard

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:

Related recalls

Same manufacturer · RemedyRepack Inc.

See all →

Same hazard · ndma contamination

See all →

Similar recalls