Drug product
Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
D-0506-2023
Product summary
- Event
- Event 92008
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33 x 30-count; 78 x 60-count bottles
- Official record key
drug-enforcement:D-0506-2023
Official wording
Reason: CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Code information: Lot # a) H3122D, Exp. Date:8/31/2024; b) Lot #A1123R, L0522E, J2622H, I1622F, H2422E, Exp. Date:8/31/2024.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations