Bimix-3 Injectables Recalled for Lack of Sterility Assurance
Bimix-3 compounded injectable (1,287 vials) recalled nationwide due to lack of sterility assurance. Patients should consult their healthcare provider about whether they received affected 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 for lack of sterility assurance in a compounded injectable medication. The absence of reported illnesses or injuries combined with Class II status (rather than Class I) prevents a higher severity score, but the hazard—inadequate sterility in injectable medications—represents a significant risk-of-harm to patients.
Plain-English summary
Olympia Compounding Pharmacy (dba Olympia Pharmacy) has recalled Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, a compounded injectable medication supplied in 2.5 mL multi-dose vials (NDC 73198-0027-03) and 10 mL multi-dose vials (NDC 73198-0027-10). The recall encompasses 1,287 vials distributed nationwide throughout the United States, Puerto Rico, and the U.S. Virgin Islands.
The FDA classified this as a Class II recall due to lack of assurance of sterility. Sterile compounding is essential for injectable medications, and failure to ensure proper sterility can pose serious safety risks to patients.
Affected lots include J24F20 and J24E20 (beyond-use date 10/20/2022) and B24G22-22 and B24F22-22 (beyond-use date 2/22/2023). Patients who received this product should contact their healthcare provider to determine whether they received a recalled batch. Do not use the affected product; consult with your healthcare provider about whether you need medical evaluation or alternative treatment options.
The recalled product
- Product
- Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi-Dose Vial, NDC73198-0027-03; b) 10 mL Multi-Dose Vial, NDC 73198-0027-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- contamination-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 (4)
- Lots: J24F20
- J24E20 BUD: 10/20/2022
- B24G22-22
- B24F22-22 BUD: 2/22/2023
Distribution
Distributed nationwide across the United States.
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