D-1875-2019 Class II Terminated
FDA drug recall D-1875-2019 was initiated by AVKARE Inc. on August 28, 2019 and is designated Class II. Reason for recall: Failed Stability Specifications. The recall status is terminated (terminated October 27, 2021). Affected quantity: 5953 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 18, 2019
- Initiation Date
- August 28, 2019
- Termination Date
- October 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5953 bottles
Product Description
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
Reason for Recall
Failed Stability Specifications.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #s: 067180011A; 067180012A, Exp. 04/2021; 06718027B1 Exp. 09/2021