Pyridoxine Injection Vials Recalled Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine HCL 100 mg/mL injection due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
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 is a Class II recall of an injectable medication with a sterility assurance issue, creating risk of serious infection. While no illnesses or injuries have been reported, the theoretical hazard of unsterile parenteral medications is inherently high-risk.
Plain-English summary
Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling approximately 1,306 vials of Pyridoxine HCL 100 mg/mL Multi-Dose injection (NDC 73198-0066-30, Lot A24018-22) due to lack of assurance of sterility. Unsterile injectable medications pose a risk of serious infection to patients who receive them.
The affected product was distributed nationwide throughout the USA, Puerto Rico, and the US Virgin Islands. All vials carry a beyond-use date of 7/18/2022.
Healthcare providers and pharmacies should stop dispensing this lot immediately. Patients who have received injections from affected vials should contact their healthcare provider. Anyone who experiences signs of infection or other adverse reactions following administration of this product should seek immediate medical attention.
The recalled product
- Product
- Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0066-30.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Injectable / Parenteral
- Hazard
- lack-of-sterility
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 (1)
- Lot: A24018-22 BUD: 7/18/2022
Distribution
Distributed nationwide across the United States.
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