FDA recall D-0651-2022

Direct Rx · Class II · drug

Product

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.)

Distribution

FL, GA, LA

Key facts

Status: Terminated
Initiation date: 2022-03-04
Report date: 2022-03-16
Termination date: 2022-12-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0651-2022