FDA-Drug2019-04-17Class III

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

AVKARE Inc.
Hazard

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

Sold states
AZ, CO
Affected count
397 bottles
Manufactured in
615 N 1st St, N/A, Pulaski, TN, United States
Products
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1122-2019

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