FDA Recalls Olympia Vita-Complex Injection Due to Sterility Concerns
Olympia Compounding Pharmacy has recalled 8,664 vials of Olympia Vita-Complex B-vitamin injection nationwide due to lack of assurance of sterility. The affected multi-dose vials may pose an infection risk to patients who receive the product.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard—lack of sterility assurance in an injectable product—poses a theoretical risk of infection to patients, placing it in the 'High' category per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Olympia Compounding Pharmacy is recalling 8,664 vials of Olympia Vita-Complex, a compounded injectable containing B vitamins (thiamine, niacinamide, riboflavin, dexpanthenol, and pyridoxine). The product is a multi-dose 30 mL vial distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
The recall was initiated due to lack of assurance of sterility in the product. For injectable medications, especially multi-dose vials that are repeatedly punctured, sterile formulation is essential to prevent microbial contamination.
The affected lots are: B24B1422 and B24E1422 (beyond-use date 8/14/2022), B24B1522 (beyond-use date 8/15/2022), and L24B15, L24C15, L24D15 (beyond-use date 6/15/2022). The product is prescription-only and was distributed to healthcare facilities and pharmacies across the United States, Puerto Rico, and the US Virgin Islands.
No illnesses or injuries have been reported in connection with this recall to date. Patients who received injections from affected lots should contact their healthcare provider.
The recalled product
- 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.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Injectable / Compounded
- Hazard
- sterility-failure
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lots: B24B1422
- B24E1422 BUD: 8/14/2022
- B24B1522 BUD: 8/15/2022
- L24B15
- L24C15
- L24D15 BUD: 6/15/2022
Distribution
Distributed nationwide across the United States.
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