FDAFDA · Food and drugs·Recall number D-0349-2022
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
Published January 12, 2022 · Recall initiated: July 27, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Perrigo Company PLC
- Distributor
- Nationwide in the USA
- Lot
- Lot # 0LE2178, Exp 01/31/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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