The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1173-2018·Announced 2018-09-12

AvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity

AvKARE is recalling Valsartan and Hydrochlorothiazide 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 rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no specific injuries are reported in the text, the presence of a carcinogen impurity in a Class II drug recall aligns with the 'Severe' tier for significant potential harm, and the rule 'If the agency's own classification is FDA Class I or USDA Class I, never go below 4' implies a high baseline for serious drug recalls, though strictly Class II is often 3 or 4. Given the 'carcinogen' nature, 4 is appropriate as it represents a significant health risk beyond minor labeling.

Plain-English summary

AvKARE Incorporated is recalling AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottles. The recall involves 12,240 bottles distributed nationwide. The specific lots affected are 17349, 18395, 19221, 20029, 20158, 20843, and 21411, with expiration dates ranging from August 2018 to September 2019.

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

Patients and healthcare providers should stop using the affected lots and contact their healthcare provider for alternative treatment options. 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
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90
Manufacturer
Avkare Incorporated
Category
Drug — Prescription Medication
Hazard
Affected units
12,240

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)

  • Lots: 17349 Exp. 08/2018
  • 18395 Exp. 08/2018
  • 19221 Exp. 06/2019
  • 20029 Exp. 06/2019
  • 20158 Exp. 07/2019
  • 20843 Exp. 07/2019
  • 21411 Exp. 09/2019.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Avkare Incorporated 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 5 products in this recall →

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