The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1021-2018·Announced 2018-08-08

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.

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 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.

See all 2 products in this recall →

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