FDAFDA · Food and drugs·Recall number D-0340-2022
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic,
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 a) 0HE2530, Exp 12/31/2021; 0JE2407, Exp 2/28/2022: b) 1BR0462, Exp 10/31/2022 c) 0FR0460, Exp 2/28/2022: 0LR0363, Exp 6/30/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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