Status
Terminated
Drug Enforcement D-0503-2023
cGMP Deviations
Classification
Class II
Report Date
April 12, 2023
Termination Date
October 19, 2023
Product Information
- Product description
- Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
- Product quantity
- —
- 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-0503-2023
- Event ID
- 91980
- Recall initiation date
- March 20, 2023
- Center classification date
- March 31, 2023
- Code info
- Lot # a): J0656821-103122, Exp. Date 11/30/2023; J0638547-080922, Exp. Date 08/31/2023; J0633575-071822, Exp. Date 07/31/2023 Lot #: b): B1965081-111622, Exp. Date 03/31/2025; B1857922-091922, B1765298-071322, B1786319-072922, B1706842-053122, Exp. Date 04/30/2023; B2003311-120822, Exp. Date 04/30/2025; B1955679-111122, Exp. Date 02/28/2025; B1878942-092922, Exp. Date 11/30/2024; B1823203-082622. Exp. Date 10/31/2024; B1706843-053122, Exp. Date 05/31/2023
- More code info
- —