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Recall Observatory FDA recall evidence

Drug product

T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835 .

D-0799-2022

April 04, 2022

Class II

Product summary

Firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Event
Event 89938
Status
Terminated
Classification
Class II
Quantity
6916 vials
Official record key
drug-enforcement:D-0799-2022

Official wording

Reason: CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information: Lots: a) D41412 BUD: 4/22/2022, E41F10 BUD: 5/10/2022, E41G10 BUD: 5/10/2022, F24D21 BUD: 6/21/2022 ; b) D41512 BUD: 4/12/2022; c) F42B21 BUD: 6/21/2022, H42B03 BUD: 8/3/2022, H42C03 BUD: 8/3/2022

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations