Recalls / Class II

Class IID-0903-2022

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

Affected lot / code info

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

Why it was recalled

Lack of assurance of sterility.

Recalling firm

Firm

Olympia Compounding Pharmacy dba Olympia Pharmacy

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

6700 Conroy Rd Ste 155, Orlando, Florida 32835-3515

Distribution

Quantity

42,722 vials

Distribution pattern

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

Timeline

Recall initiated

2022-05-09

FDA classified

2022-05-25

Posted by FDA

2022-06-01

Status

Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-0903-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.