PlainRecalls
FDA Drug Moderate Class II Terminated

Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

Reported: April 12, 2023 Initiated: March 20, 2023 #D-0503-2023

Product Description

Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

Reason for Recall

cGMP Deviations

Details

Recalling Firm
RemedyRepack Inc.
Distribution
RemedyRepack distributed product to consignees nationwide within the United States
Location
Indiana, PA

Frequently Asked Questions

What product was recalled?
Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. Recalled by RemedyRepack Inc..
Why was this product recalled?
cGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on April 12, 2023. Severity: Moderate. Recall number: D-0503-2023.