RemedyRepack Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity
RemedyRepack Inc. is recalling specific lots of Valsartan/HCTZ 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 criteria for Severe severity (FDA Class II with significant health risks).
Plain-English summary
RemedyRepack Inc. is recalling Valsartan/HCTZ 320mg/12.5 mg tablets, 90-count bottles, due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated after a carcinogen impurity was detected in the active pharmaceutical ingredient (API) used to manufacture the drug product.
The affected product is identified by Lot # B0383153-122917 with an expiration date of 12/18. The product was distributed to three medical facilities in Florida. The quantity involved is 3 HDPE 90-count bottles, totaling 270 tablets.
Patients and medical facilities should stop using the affected product and contact their healthcare provider for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Antihypertensive
- 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 (2)
- Lot # B0383153-122917
- Exp. 12/18
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by RemedyRepack 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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