D-0498-2023 Class II Terminated
FDA drug recall D-0498-2023 was initiated by RemedyRepack Inc. on March 20, 2023 and is designated Class II. Reason for recall: cGMP Deviations The recall status is terminated (terminated October 19, 2023). Affected quantity: 3,426 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 12, 2023
- Initiation Date
- March 20, 2023
- Termination Date
- October 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,426 bottles
Product Description
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.
Reason for Recall
cGMP Deviations
Distribution Pattern
RemedyRepack distributed product to consignees nationwide within the United States
Code Information
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