D-0289-2022 Class II Terminated
FDA drug recall D-0289-2022 was initiated by The Harvard Drug Group on August 3, 2021 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated July 16, 2023). Affected quantity: 2,239 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 29, 2021
- Initiation Date
- August 3, 2021
- Termination Date
- July 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,239 bottles
Product Description
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide USA
Code Information
Lot, expiry: Lot H00005, exp 01/2022; Lot H00006, exp 04/2022; Lot H00007, exp 07/2022