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Recall Observatory FDA recall evidence

Drug product

GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy

D-0728-2022

March 23, 2022

Class II

Product summary

Firm
Drug Depot, Inc., dba APS Pharmacy
Event
Event 89808
Status
Terminated
Classification
Class II
Quantity
6017 vials
Official record key
drug-enforcement:D-0728-2022

Official wording

Reason: Lack of sterility assurance.

Code information: Lots: 745708 BUD: 6/21/2022; 753364 BUD: 7/27/2022; 752508 BUD: 7/24/2022; 750313 BUD: 7/16/2022; 753020 BUD: 7/26/2022; 747712 BUD: 7/4/2022; 747974 BUD: 7/5/2022; 754802 BUD: 8/3/2022; 751158 BUD: 7/19/2022; 756837 BUD: 8/16/2022; 748939 BUD: 7/10/2022; 750842 BUD: 7/18/2022; 755742 BUD: 8/8/2022; 758691 BUD: 8/28/2022; 758432 BUD: 8/27/2022; 758975 BUD: 8/29/2022; 756643 BUD: 8/15/2022

Distribution pattern: Nationwide in the USA including Puerto Rico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility