FindMyRecallSubscribe
Class III: unlikely to cause harmTerminated

Avkare Telmisartan and Amlodipine Tablets 80 mg/5 mg Recall

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for:…

AVKARE Inc. · Pulaski, TN

Risk level
Class III
Reported by FDA
Apr 17, 2019
Recall ID
D-1122-2019
Check your lot numberHow we source this data

Summary

Avkare recalled Telmisartan and Amlodipine Tablets 80 mg/5 mg starting Apr 3, 2019. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1122-2019 on Apr 17, 2019. Reason: Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer). Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)

Product description

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30

Lot numbers, UPCs & expiration codes

Lots: 201916 Exp. 08/2019; 20092 Exp. 08/2019

Where it was sold

AZ, CO

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-1122-2019
Classification
Class III
Status
Terminated
Recall initiated
Apr 3, 2019
FDA report date
Apr 17, 2019
Quantity
397 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
AVKARE Inc.

Original FDA data

Every field from FDA enforcement report D-1122-2019, exactly as published.

Show all FDA fields
City
Pulaski
State
TN
Status
Terminated
Country
United States
Event ID
82564
Address
615 N 1st St
Code information
Lots: 201916 Exp. 08/2019; 20092 Exp. 08/2019
Postal code
38478-2403
Report date
Apr 17, 2019
Product type
Drugs
Recall number
D-1122-2019
Classification
Class III
Recalling firm
AVKARE Inc.
Product quantity
397 bottles
Termination date
May 7, 2020
Reason for recall
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Voluntary / mandated
Voluntary: Firm initiated
Product description
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
Distribution pattern
AZ, CO
Recall initiation date
Apr 3, 2019
Initial firm notification
Letter
Center classification date
Apr 11, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1122-2019, published Apr 17, 2019. 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