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Recall Observatory FDA recall evidence

Drug product

Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.

D-0797-2022

April 04, 2022

Class II

Product summary

Firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Event
Event 89938
Status
Terminated
Classification
Class II
Quantity
18060 vials
Official record key
drug-enforcement:D-0797-2022

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) D41019 BUD: 4/19/2022; b) D41112 BUD: 4/12/2022, D47028 BUD: 4/28/2022, F24009 BUD 3/4/2022, F41001 BUD: 6/1/2022, G48006 BUD: 7/14/2022, G48008 BUD: 7/8/2022, G48012 BUD: 7/12/2022, G48014 BUD: 7/14/2022, G48019 BUD: 7/9/2022, I24009 BUD: 9/9/2022, I41107 BUD: 9/7/2022

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations