Recalls / Class II
Class IID-0796-2022
Product
Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. 73198-0113-10
- Affected lot / code info
- Lots: D41012 BUD 4/12/2022, D41212 BUD: 4/12/2022, D47026 BUD: 4/26/2022, E41017 BUD: 5/17/2022, E41018 BUD: 5/18/2022, E47004 BUD: 5/4/2022, E47024 BUD: 5/24/2022, E47026 BUD: 5/26/2022, E48005 BUD: 5/5/2022, G47014 BUD: 7/14/2022, H48816 BUD: 8/16/2022
Why it was recalled
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
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
- 45,935 vials
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2022-04-04
- FDA classified
- 2022-04-27
- Posted by FDA
- 2022-05-04
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0796-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.