Baxter Healthcare Injectable Ondansetron Recalled for Failed pH Specifications
Baxter Healthcare Corporation is recalling approximately 6 million vials of Ondansetron Hydrochloride injection due to manufacturing defects where pH levels failed to meet specifications.
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: FDA Class II recall for manufacturing defect affecting product specification. No illnesses or injuries have been reported in the source material; the hazard is a quality control failure posing theoretical risk.
Plain-English summary
Baxter Healthcare Corporation is recalling Ondansetron Hydrochloride Injection, USP (4 mg/2 mL) due to failed pH specifications. Ondansetron is an injectable medication used to prevent nausea and vomiting.
The recall affects approximately 6,022,675 vials distributed nationwide in the United States. The product was manufactured by Baxter Pharmaceuticals India Private Ltd and distributed under NDC 36000-012-25. Multiple lot numbers are affected with expiration dates ranging from November 2023 through October 2024.
Healthcare providers should not dispense affected vials. Patients currently using this medication should consult their healthcare provider for guidance. Retailers and distributors should quarantine and return affected lot numbers to Baxter Healthcare Corporation.
The recalled product
- Product
- ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
- Brand
- ONDANSETRON HYDROCHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 6,022,675
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 (20)
- Lot # A0E0959A
- A0E0961A
- A0E1015A
- A0E1020A
- Exp. Date 30-Nov-23
- A0F0016A
- Exp. Date 31-Dec-23
- A0F0260A
- A0F0261A
- A0F0262A
- Exp. Date 29-Feb-24
- A0F0414A
- A0F0415A
- A0F0416A
- A0F0417A
- A0F0418A
- Exp. Date 30-Apr-24
- A0F0503A
- Exp. Date 31-May-24
- A0F0533A
UPCs (1)
- 0336000012256
Distribution
Distributed nationwide across the United States.
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