PlainRecalls
FDA Drug Moderate Class II Terminated

Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

Reported: April 12, 2023 Initiated: March 20, 2023 #D-0493-2023

Product Description

Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

Reason for Recall

cGMP Deviations

Details

Recalling Firm
RemedyRepack Inc.
Units Affected
a) 147 bottles, b)70 bottles, c) 3 bottles
Distribution
RemedyRepack distributed product to consignees nationwide within the United States
Location
Indiana, PA

Frequently Asked Questions

What product was recalled?
Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. Recalled by RemedyRepack Inc.. Units affected: a) 147 bottles, b)70 bottles, c) 3 bottles.
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-0493-2023.