Recalls / Class III
Class IIID-1122-2019
Product
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
- Affected lot / code info
- Lots: 201916 Exp. 08/2019; 20092 Exp. 08/2019
Why it was recalled
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Recalling firm
- Firm
- AVKARE Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 397 bottles
- Distribution pattern
- AZ, CO
Timeline
- Recall initiated
- 2019-04-03
- FDA classified
- 2019-04-11
- Posted by FDA
- 2019-04-17
- Terminated
- 2020-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1122-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.