Agency classClass IIOur severity:High FDA (Drugs)·D-0946-2022·Announced 2022-06-01

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
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

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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.

See all 53 products in this recall →

Same manufacturer · Olympia Compounding Pharmacy dba Olympia Pharmacy

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