# FDA recall D-0342-2022

> **Perrigo Company PLC** · Class II · drug recall initiated 2021-07-27.

## Product

MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle,   Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9

## Reason for recall

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0342-2022
- **Recalling firm:** Perrigo Company PLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-07-27
- **Report date:** 2022-01-12
- **Termination date:** 2022-11-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allegan, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0342-2022

## Citation

> AI Analytics. FDA recall D-0342-2022. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-0342-2022. Source: US FDA. Licensed CC0.

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