US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jun 19, 2019 (7 years ago)

Ondansetron 2 Mg/Ml Injection Solution

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility

What was recalled

ONDANSETRON 2 MG/ML INJECTION SOLUTION (PFV), 2 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0158-02

Recalling firm
RXQ Compounding LLC
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1691-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Ondansetron recalls

See all
Class II · Moderate risk Ongoing

Ondansetron Orally Disintegrating Tablets

Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

Glenmark Pharmaceuticals Inc., USA NDC 68462-157-13 D-0246-2026
Class II · Moderate risk Ongoing

Ondansetron ODT Tablets

Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

Preferred Pharmaceuticals, Inc. NDC 68788-8666-01 D-0239-2026
Class II · Moderate risk Completed

Ondansetron Injection

Reason Failed pH Specifications

Baxter Healthcare Corporation NDC 36000-012-25 D-0146-2024
Class II · Moderate risk Terminated

Ondansetron 8mg in Ns 100ml

Reason Lack of sterility assurance

Sentara Infusion Services D-0312-2023
Class II · Moderate risk Completed

Ondansetron Hydrochloride

Reason Lack of assurance of sterility.

Olympia Compounding Pharmacy dba Olympia Pharmacy NDC 73198-0127-30 D-0943-2022