# FDA recall D-1122-2019

> **AVKARE Inc.** · Class III · drug recall initiated 2019-04-03.

## Product

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

AZ, CO

## Key facts

- **Recall number:** D-1122-2019
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-03
- **Report date:** 2019-04-17
- **Termination date:** 2020-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall D-1122-2019. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1122-2019. Source: US FDA. Licensed CC0.

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