PlainRecalls
FDA Drug Moderate Class II Terminated

AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0490-2021

Product Description

AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
122 bottles
Distribution
FL, GA, SC
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724. Recalled by Cardinal Health Inc.. Units affected: 122 bottles.
Why was this product recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0490-2021.