RemedyRepack Recalls Amlodipine/Valsartan HCTZ Tablets Due to NDMA Contamination
RemedyRepack Inc. is recalling Amlodipine/Valsartan HCTZ tablets due to trace amounts of NDMA 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contaminants.
Plain-English summary
RemedyRepack Inc. is recalling Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets. The recall is due to the detection of trace amounts of NDMA, a possible impurity or contaminant, in an active pharmaceutical ingredient.
The affected product consists of 2 bottles of 90 tablets (180 tablets) in HDPE 90 cc bottles in cardboard trays. The original NDC is 13668-0325-30 and the repackaged NDC is 70518-1220-00. The specific lot number is B0438903-052118.
The product was distributed to a medical facility in South Carolina. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
- 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 (1)
- Lot # B0438903-052118 70518-1220-00
Distribution
Distributed in 1 state:
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