D-0497-2023 Class II Terminated
FDA drug recall D-0497-2023 was initiated by RemedyRepack Inc. on March 20, 2023 and is designated Class II. Reason for recall: cGMP Deviations The recall status is terminated (terminated October 19, 2023). Affected quantity: 16 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 12, 2023
- Initiation Date
- March 20, 2023
- Termination Date
- October 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 bottles
Product Description
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
Reason for Recall
cGMP Deviations
Distribution Pattern
RemedyRepack distributed product to consignees nationwide within the United States
Code Information
Lot #: B1635780-040522, Exp. Date 04/30/2023