Status
Terminated
Drug Enforcement D-0492-2023
cGMP Deviations
Classification
Class II
Report Date
April 12, 2023
Termination Date
October 19, 2023
Product Information
- Product description
- Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
- Product quantity
- a) 58 bottles, b) 6 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-0492-2023
- Event ID
- 91980
- Recall initiation date
- March 20, 2023
- Center classification date
- March 31, 2023
- Code info
- Lot #: a) J0665197-120522, Exp. Date 12/31/2023; J0642497-082722, Exp. Date 09/30/2023 J0638552-080922, Exp. Date 08/31/2023. Lot #: b) B1808799-081622, Exp. Date 05/31/2024
- More code info
- —