The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1020-2018·Announced 2018-08-08

RemedyRepack Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

RemedyRepack Inc. is recalling Valsartan/HCTZ 160 mg/12.5 mg 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 agency classification is FDA Class II, and the hazard involves a carcinogen impurity, which aligns with the 'Severe' criteria for significant health risks.

Plain-English summary

RemedyRepack Inc. is recalling Valsartan/HCTZ 160 mg/12.5 mg tablets, 90-count bottles, prescription only. The recall involves 4 HDPE 90-count bottles (360 tablets) with Lot # B0318652-070617 and an expiration date of 07/18.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of a carcinogen impurity in the active pharmaceutical ingredient (API) used to manufacture the drug product.

The affected product was distributed to 3 medical facilities in Florida. Patients who may have received this medication should contact their healthcare provider for guidance on alternative treatment options.

The recalled product

Product
Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
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 (2)

  • Lot # B0318652-070617
  • Exp. 07/18

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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