Status
Ongoing
Drug Enforcement D-0508-2023
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Classification
Class II
Report Date
April 12, 2023
Termination Date
—
Product Information
- 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.
- Product quantity
- 349 bottles
- Reason for recall
- CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Direct Rx
- Address
-
94 Worldwide Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0508-2023
- Event ID
- 92054
- Recall initiation date
- March 22, 2023
- Center classification date
- April 6, 2023
- Code info
- 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.
- More code info
- —