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Recall Observatory FDA recall evidence

Drug product

Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3

D-0504-2023

March 27, 2023

Class II

Product summary

Firm
Preferred Pharmaceuticals, Inc.
Event
Event 92008
Status
Terminated
Classification
Class II
Quantity
30 Bottles
Official record key
drug-enforcement:D-0504-2023

Official wording

Reason: CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Code information: Lot: G1822K, Exp. Date:5/31/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations