The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1102-2018·Announced 2018-08-22

RemedyRepack Recalls Valsartan 320 mg Tablets Due to Carcinogen Impurity

RemedyRepack Inc. is recalling specific lots of Valsartan 320 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 the hazard involves a carcinogen impurity, which constitutes a significant health risk and fits the 'Severe' criteria for significant injury/property-damage reports or high-risk contamination.

Plain-English summary

RemedyRepack Inc. is recalling Valsartan 320 mg Tablets (NDC 61786-0793-19) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated because a carcinogen impurity was detected in the active pharmaceutical ingredient (API) used to manufacture the drug product.

The affected product consists of 36 bottles of 90 tablets each (3,240 tablets total) in HDPE 90 cc bottles in cardboard trays. The specific lots subject to recall are B0362988-110917 (exp. 10/2018), B0432265-050318 (exp. 05/2019), B0450321-061218 (exp. 06/2019), B0450322-061218 (exp. 05/2019), and B0408652-030718 (exp. 02/2019).

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 prescribed this specific medication.

The recalled product

Product
Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19
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 (6)

  • Lot # B0362988-110917
  • exp. date 10/2018 Lot # B0432265-050318
  • exp. date 05/2019 Lot # B0450321-061218
  • exp. date 06/2019 Lot # B0450322-061218
  • exp. date 05/2019 Lot # B0408652-030718
  • exp. date 02/2019

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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