PlainRecalls
FDA Drug Moderate Class II Terminated

Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60

Reported: March 16, 2022 Initiated: March 4, 2022 #D-0650-2022

Product Description

Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60

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
16 bottles
Distribution
FL, GA, LA
Location
Dawsonville, GA

Frequently Asked Questions

What product was recalled?
Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60. Recalled by Direct Rx. Units affected: 16 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-0650-2022.