Recalls / Class II
Class IID-0932-2022
Product
Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline Chloride 25 mg/mL Thiamine HCL (B1) 50 mg/mL Riboflavin5P04 (B2) 5 mg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0130-10; b) 30 mL Multi-Dose vial, NDC 73198-0130-30; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
- Affected lot / code info
- Lots: A24103 BUD: 7/3/2022; B41B01-22 BUD: 8/1/2022
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
- 3762 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-0932-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.