D-0650-2022 Class II Terminated

Recalled by Direct Rx — Dawsonville, GA

Recall Details

Product Type
Drugs
Report Date
March 16, 2022
Initiation Date
March 4, 2022
Termination Date
December 2, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16 bottles

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.)

Distribution Pattern

FL, GA, LA

Code Information

Lot #: 19AU1910 Exp. 5/31/22