Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, In...
FDA Recall #D-1122-2019 — Class III — April 3, 2019
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)
Recalling Firm
AVKARE Inc. — Pulaski, TN
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
397 bottles
Distribution
AZ, CO
Code Information
Lots: 201916 Exp. 08/2019; 20092 Exp. 08/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated