Recalls / Class II
Class IID-0498-2023
Product
Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
- Affected lot / code info
- Lot #: a) J0659819-110922, Exp. Date 11/30/2023; J0649932-093022, J0649917-093022 Exp. Date 10/31/2023, B2010060-121222, Exp. Date 03/31/24 Lot #: b) B1708575-060122, Exp. Date 05/31/2023; B1879236-092922, Exp. Date 12/31/2023
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
- 3,426 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-0498-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.