AVKARE Inc. recalls Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --…
- Recall date
- April 3, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1122-2019
- FDA classification
- Class III
- Brand / firm
- AVKARE Inc.
- Sold / distributed
- AZ, CO
Why it was recalled
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
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