D-0339-2022 Class II Terminated
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
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9
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 0JE2491, 0LE2178, Exp 01/31/2022; 0ME2516, Exp 4/30/2022