Recalls / Class II
Class IID-0491-2023
Product
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.
- Affected lot / 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
Why it was recalled
cGMP Deviations
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- a) 3,497 bottles, b) 729 bottles
- Distribution pattern
- RemedyRepack distributed product to consignees nationwide within the United States
Timeline
- Recall initiated
- 2023-03-20
- FDA classified
- 2023-03-31
- Posted by FDA
- 2023-04-12
- Terminated
- 2023-10-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0491-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.