The Recall Desk
SevereFDA (Drugs)·D-1130-2018·Announced 2018-09-05

AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity in API

AvKARE is recalling Valsartan Tablets 40 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the drug.

What this means for you

Illness, injury, or structural failure has been reported. 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 meets the rubric criteria for a Severe rating (FDA Class II with significant injury/property-damage reports or high-risk hazards).

Plain-English summary

AvKARE, Inc. is recalling Valsartan Tablets, USP 40 mg (NDC 50268-783-15) 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 recall involves 6,776 cartons (338,800 tablets) of the 50-tablet unit dose packaging. The affected lots are 18491 (Exp. 10/2018), 19531 (Exp. 04/2019), 20168 (Exp. 05/2019), 20671 (Exp. 08/2019), 21049 (Exp. 10/2019), and 21635 (Exp. 10/2019). The products were distributed nationwide in the United States.

Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider for guidance on alternative treatments. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Manufacturer
AVKARE 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)

  • Lots: 18491 Exp. 10/2018
  • 19531 Exp. 04/2019
  • 20168 Exp. 05/2019
  • 20671 Exp. 08/2019
  • 21049 Exp. 10/2019
  • 21635 Exp. 10/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by AVKARE 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 4 products in this recall →

Related recalls

Same manufacturer · AVKARE Inc.

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Same hazard · carcinogen impurity

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