D-0349-2022 Class II Terminated
FDA drug recall D-0349-2022 was initiated by Perrigo Company PLC on July 27, 2021 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. The recall status is terminated (terminated November 8, 2022). Affected quantity: 26,304 containers.
Recall Details
- Product Type
- Drugs
- Report Date
- January 12, 2022
- Initiation Date
- July 27, 2021
- Termination Date
- November 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,304 containers
Product Description
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3
Reason for Recall
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 0LE2178, Exp 01/31/2022