FDA Recalls Olympia Mineral Blend Injectable for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls 6,113 vials of Olympia Mineral Blend injectable due to lack of assurance of sterility. The product was distributed nationwide; patients should not use it and should consult their healthcare provider.
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: This FDA Class II recall addresses a theoretical risk of sterility failure in an injectable product without any reported illnesses, injuries, or hospitalizations, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympia Compounding Pharmacy is recalling Olympia Mineral Blend (Magnesium Chloride 80 mg/mL, Zinc Sulfate 1 mg/mL, Manganese Sulfate 20 mcg/mL, Copper Gluconate 0.2 mg/mL, and Sodium Selenite 18 mcg/mL) in 30 mL multi-dose vials. Approximately 6,113 vials are affected by this recall.
The product is being recalled due to lack of assurance of sterility. The affected lots include L24B1 with beyond-use date of 6/16/2022, L24D16 with beyond-use date of 6/16/2022, A24C24-22, and A24E24-22 with beyond-use date of 7/24/2022. This injectable product has been distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Patients who have been administered this product should not use it and should contact their healthcare provider for guidance on alternative treatments. Healthcare providers should discontinue use of affected lots and consult with Olympia Compounding Pharmacy or their patient care team regarding appropriate follow-up.
The recalled product
- Product
- Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate 20 mcg/mL Copper Gluconate 0.2 mg/mL Sodium Selenite 18 mcg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0061-30.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Hazard
- sterility-failure
- 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: L24B1 BUD: 6/16/2022
- L24D16 BUDL 6/16/2022
- A24C24-22
- A24E24-22 BUDL 7/24/2022
Distribution
Distributed nationwide across the United States.
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