D-0508-2023 Class II Ongoing

Recalled by Direct Rx — Dawsonville, GA

Recall Details

Product Type
Drugs
Report Date
April 12, 2023
Initiation Date
March 22, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
349 bottles

Product Description

Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.

Reason for Recall

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Distribution Pattern

Nationwide in the USA

Code Information

Lots: a) 03FE2318, Exp. 8/31/24; b) 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, Exp. 8/31/24; 17FE2203, 12AP2204, 17MA2205, Exp. 3/31/23; 21JU2206, 22JU2220, 12JY2206, Exp. 5/31/23; 10AU2209, Exp. 6/30/23; 14DE2215, Exp. 9/30/24; 05JA2304, 27JA2301, Exp. 11/30/24.