Agency classClass IIOur severity:High FDA (Drugs)·D-0943-2022·Announced 2022-06-01

Ondansetron Hydrochloride vials recalled due to sterility assurance concerns

Olympia Compounding Pharmacy recalls 911 vials of Ondansetron Hydrochloride (1 mg/mL) 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 an FDA Class II recall of a parenteral drug product with sterility assurance concerns. While no illnesses or injuries have been reported, the theoretical risk of infection from an injectable product with unassured sterility qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.

Plain-English summary

Olympia Compounding Pharmacy is recalling 911 vials of Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose 30 mL vials (NDC 73198-0127-30). The recalled lot is B24015-22 with a Beyond Use Date of 8/15/2022.

The product is being recalled because the manufacturer cannot assure that the vials maintain their sterility. This is a significant concern for multi-dose vials intended for injection, as lack of sterility can pose a risk of infection.

The recalled vials were distributed nationwide in the United States, Puerto Rico, and the U.S. Virgin Islands.

Patients and healthcare providers who have received this product should discontinue use immediately and consult with their healthcare provider about alternative treatments. Healthcare facilities should verify their inventory against the lot number and remove any affected product from circulation.

The recalled product

Product: Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0127-30.
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Injectable
Hazard: sterility-failure
contamination-risk
infection-risk
Affected units: 911

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: B24015-22 BUD: 8/15/2022

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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