Status
Terminated
Drug Enforcement D-0491-2023
cGMP Deviations
Classification
Class II
Report Date
April 12, 2023
Termination Date
October 19, 2023
Product Information
- Product description
- Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
- Product quantity
- a) 3,497 bottles, b) 729 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-0491-2023
- Event ID
- 91980
- Recall initiation date
- March 20, 2023
- Center classification date
- March 31, 2023
- Code info
- Lot #: a) J0679046-020123, Exp. Date 02/28/2024; J0669807-122122, Exp. Date 01/31/2024; J0662695-112222, Exp. Date 12/31/2023; J0654076-101822, J0654076-101822, Exp. Date 11/30/2023; J0642765-082922, Exp. Date 09/30/2023 Lot #: b) B1672408-050322, B1765902-071322, B1769634-071622, Exp. Date 04/30/2023; B1776907-072122, Exp. Date 09/30/2023; B1836636-090322, Exp. Date 11/30/2023; B1870344-092422, Exp. Date 01/31/2024; B1908452-101522, B1966455-111722, B2043099-010423, Exp. Date 05/31/2024
- More code info
- —