Pyridoxine Injection Vials Recalled by FDA Due to Sterility Failure
Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine 100 mg/mL injectable due to lack of assurance of sterility. The multi-dose vials were distributed nationwide and may pose infection risk if administered.
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 involves an injectable medication with unverified sterility. Although no illnesses have been reported, the lack of sterility assurance on an injectable represents a significant risk of harm through infection, meeting the criteria for risk-of-harm products without reported injury.
Plain-English summary
Olympia Compounding Pharmacy is recalling 1,306 vials of Pyridoxine 100 mg/mL, a multi-dose injectable. The recalled lot (A24018-22, with an expiration date of 7/18/2022) was distributed nationwide throughout the USA, Puerto Rico, and the US Virgin Islands.
The recall was initiated due to lack of assurance of sterility. Injectable medications must be sterile to prevent infection. Without verified sterility, the multi-dose vials may contain bacterial or fungal contamination that could cause serious infections when administered.
Patients who may have received this medication should contact their healthcare provider. Healthcare facilities and pharmacies that received or dispensed the product should identify affected patients and quarantine remaining vials with lot number A24018-22. These vials should not be used.
The recalled product
- Product
- Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0066-30
- Category
- Drug — Prescription Injectable
- Affected units
- 1,306
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
Part of a larger recall action
This product is one of 53 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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