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Recall Observatory FDA recall evidence

Drug product

Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.

D-0654-2022

March 02, 2022

Class II

Product summary

Firm
Golden State Medical Supply Inc.
Event
Event 89712
Status
Terminated
Classification
Class II
Quantity
401 bottles
Official record key
drug-enforcement:D-0654-2022

Official wording

Reason: CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.

Code information: Lot #: GS027852, Expiry: 06/2022.

Distribution pattern: Distributed to 1 wholesaler/distributor

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviation