PlainRecalls
FDA Drug Moderate Class II Terminated

Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60

Reported: March 16, 2022 Initiated: March 4, 2022 #D-0651-2022

Product Description

Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60

Reason for Recall

CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)

Details

Recalling Firm
Direct Rx
Units Affected
8 bottles
Distribution
FL, GA, LA
Location
Dawsonville, GA

Frequently Asked Questions

What product was recalled?
Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60. Recalled by Direct Rx. Units affected: 8 bottles.
Why was this product recalled?
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Which agency issued this recall?
This recall was issued by the FDA Drug on March 16, 2022. Severity: Moderate. Recall number: D-0651-2022.