Status
Terminated
Drug Enforcement D-0497-2023
cGMP Deviations
Classification
Class II
Report Date
April 12, 2023
Termination Date
October 19, 2023
Product Information
- Product description
- Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
- Product quantity
- 16 bottles
- Reason for recall
- cGMP Deviations
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- RemedyRepack distributed product to consignees nationwide within the United States
Location & Firm
- Recalling firm
- RemedyRepack Inc.
- Address
-
625 Kolter Dr Ste 4
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0497-2023
- Event ID
- 91980
- Recall initiation date
- March 20, 2023
- Center classification date
- March 31, 2023
- Code info
- Lot #: B1635780-040522, Exp. Date 04/30/2023
- More code info
- —