The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1100-2018·Announced 2018-08-22

RemedyRepack Recalls Valsartan 80 mg Tablets Due to Carcinogen Impurity

RemedyRepack Inc. is recalling Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the product.

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 the hazard involves a carcinogen impurity, which constitutes a significant health risk warranting a Severe rating under the rubric for significant injury/property-damage reports or high-risk contamination.

Plain-English summary

RemedyRepack Inc. is voluntarily recalling Valsartan 80 mg tablets, packaged in HDPE 90 cc bottles in cardboard trays. The recall is 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 is identified by NDC 61786-0791-19. The recall includes six specific lot numbers: B0335344-081717 (exp. 08/2018), B0363364-110917 (exp. 11/2018), B0391225-012218 (exp. 01/2019), B0408458-030618 (exp. 03/2019), B0384871-010318 (exp. 01/2019), and B0436862-051518 (exp. 05/2019). Each unit consists of 9 bottles of 90 tablets, totaling 810 tablets.

The product was distributed to three customers in Florida and Virginia. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they have been taking the affected medication.

The recalled product

Product
Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19
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 (7)

  • Lot # B0335344-081717
  • exp. date 08/2018 Lot # B0363364-110917
  • exp. date 11/2018 Lot # B0391225-012218
  • exp. date 01/2019 Lot # B0408458-030618
  • exp. date 03/2019 Lot # B0384871-010318
  • exp. date 01/2019 Lot # B0436862-051518
  • exp. date 05/2019

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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