Drug product
Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
D-0505-2023
Product summary
- Event
- Event 92008
- Status
- Terminated
- Classification
- Class II
- Quantity
- 320 x 30-count; 46 x 60-count; 10 x 90-count bottles
- Official record key
drug-enforcement:D-0505-2023
Official wording
Reason: CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Code information: Lot # a) D2022P, Exp. Date:4/30/2023; F1022Y, E2022, I2822U, Exp. Date:6/30/2023; L2122W, Exp. Date: 8/31/2024; b) Lot #L0522A, Exp. Date:8/31/2024; B0823J, Exp. Date:11/31/2024; c) Lot# L1522P, Exp. Date: 10/31/2024.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations