Recall archive / FDA drug enforcement
Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dos... — FDA record D-0796-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 4, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- Classification
- Class II
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Quantity
- 45,935 vials
- Agency-reported status
- Terminated
- Source record identifier
- D-0796-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed Nationwide in the USA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 4, 2022
- Recall initiation date
- Apr 4, 2022
- Center classification date
- Apr 27, 2022
- Termination date
- Jun 17, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.