Recalls / Class II
Class IID-0921-2022
Product
Calcium Chloride 10% (100 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0064-30
- Affected lot / code info
- Lots: B24C21-22 BUD: 8/21/2022, B24B21-22 BUD: 8/21/2022, A24010-22 BUD: 7/10/2022, A24110-22 BUD: 7/10/2022
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
- 5443 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-0921-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.