Drug product

Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0113-10

D-0903-2022

May 09, 2022

Class II

Product summary

Firm: Olympia Compounding Pharmacy dba Olympia Pharmacy
Event: Event 90204
Status: Completed
Classification: Class II
Quantity: 42,722 vials
Official record key: drug-enforcement:D-0903-2022

Official wording

Reason: Lack of assurance of sterility.

Code information: Lots: J24125, J24025 BUD: 10/25/2022; K24002 BUD: 11/2/2022; L24013, L24213 BUD: 12/13/2022; A24003 BUD: 1/3/2023; A24404 BUD: 1/4/2023; A24031-22 BUD: 1/31/2023; B24001-22 BUD: 2/1/2023

Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of assurance of sterility