Drug product
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
D-1122-2019
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 82564
- Status
- Terminated
- Classification
- Class III
- Quantity
- 397 bottles
- Official record key
drug-enforcement:D-1122-2019
Official wording
Reason: Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Code information: Lots: 201916 Exp. 08/2019; 20092 Exp. 08/2019
Distribution pattern: AZ, CO
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications