D-1122-2019 Class III Terminated
FDA drug recall D-1122-2019 was initiated by AVKARE Inc. on April 3, 2019 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer) The recall status is terminated (terminated May 7, 2020). Affected quantity: 397 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 17, 2019
- Initiation Date
- April 3, 2019
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 397 bottles
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
Reason for Recall
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Distribution Pattern
AZ, CO
Code Information
Lots: 201916 Exp. 08/2019; 20092 Exp. 08/2019