FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

AvKARE Valsartan and Hydrochlorothiazide 80 Recall

AvKARE Valsartan and Hydrochlorothiazide 80 mg/12

Avkare Incorporated · Pulaski, TN

Risk level
Class II
Reported by FDA
Sep 12, 2018
Recall ID
D-1173-2018
Check your lot numberHow we source this data

Summary

Avkare recalled AvKARE Valsartan and Hydrochlorothiazide 80 starting Jul 18, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1173-2018 on Sep 12, 2018. Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Status: Terminated.

Why it was recalled

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Product description

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

Lot numbers, UPCs & expiration codes

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.

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1173-2018
Classification
Class II
Status
Terminated
Recall initiated
Jul 18, 2018
FDA report date
Sep 12, 2018
Quantity
12240 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Avkare Incorporated

Original FDA data

Every field from FDA enforcement report D-1173-2018, exactly as published.

Show all FDA fields
City
Pulaski
State
TN
Status
Terminated
Country
United States
Event ID
80940
Address
114 S 1st St
Code information
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.
Postal code
38478-3216
Report date
Sep 12, 2018
Product type
Drugs
Recall number
D-1173-2018
Classification
Class II
Recalling firm
Avkare Incorporated
Product quantity
12240 bottles
Termination date
May 7, 2020
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide
Recall initiation date
Jul 18, 2018
Initial firm notification
Letter
Center classification date
Sep 6, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1173-2018, published Sep 12, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls