Recalls / Class II
Class IID-0942-2022
Product
Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL Riboflavin 5 P04 (B2) 2 mg/mL Dexpanthenol (B5) 2 mg/mL Pyridoxine HCL (B6) 2 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0063-30.
- Affected lot / code info
- Lots: B24B1422, B24E1422 BUD: 8/14/2022, B24B1522 BUD: 8/15/2022, L24B15, L24C15, L24D15 BUD: 6/15/2022
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
- 8664 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-0942-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.