Recall D-0496-2023
Description: Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Recall D-0496-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0496-2023 |
Event ID | 91980 |
Distribution | RemedyRepack distributed product to consignees nationwide within the United States |
Quantity | a) 1,262 bottles, b) 95 bottles |
Recall Reason | cGMP Deviations |
Drug Classification | Class II |
Drug Code Info | 20230412 |
Recall Initiation Date | 20230320 |
Report Date | 20230412 |
Classification Date | 20230331 |
Address | 625 Kolter Dr Ste 4 Indiana, PA 15701-3571 United States |
Recalling Firm | RemedyRepack Inc. |
Initial Notification | Letter |
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