Class II
Terminated
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90 count bottle, NDC 36800-319-75 UPC 0 36800 33282 9; Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic,
This recall has been terminated (originally issued January 12, 2022).
- Company
- Perrigo Company Plc
- Recall Initiated
- July 27, 2021
- Posted
- January 12, 2022
- Recall Number
- D-0350-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13,656 containers
- Firm Location
- Allegan, MI, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Distribution
Nationwide in the USA
Lot / Code Info
Lot # a) 0KE2429, Exp 02/28/2022; b) 0HE2530, Exp 12/31/2021; c)0FR0460, Exp 02/28/2022; d)0GR0531, Exp 03/31/2022 ; 0KR0465, Exp 04/302022
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