The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1101-2018·Announced 2018-08-22

RemedyRepack Recalls Valsartan 160 mg Tablets Due to Carcinogen Impurity

RemedyRepack Inc. is recalling Valsartan 160 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 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 risk).

Plain-English summary

RemedyRepack Inc. is recalling Valsartan 160 mg Tablets, packaged in HDPE 90 cc bottles in cardboard trays. The recall involves specific lots identified by NDC 61786-0792-19.

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 product was distributed to three customers in Florida and Virginia. Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance on alternative treatments.

The recalled product

Product
Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
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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