Ondansetron Tablets Recalled for Temperature Exposure During Storage
McKesson is recalling Ondansetron Hydrochloride 8 mg tablets distributed nationwide due to temperature abuse during storage that may affect medication stability. Patients should contact their pharmacy or doctor.
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 indicates a serious manufacturing defect. Although no illnesses or injuries have been reported, temperature abuse is a documented quality deviation that could compromise medication stability and effectiveness, warranting High severity.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Ondansetron Hydrochloride 8 mg tablets due to current Good Manufacturing Practice (cGMP) deviations related to temperature abuse that may have compromised product stability. The affected product is Ondansetron 8 mg film-coated tablets in 30-count bottles, distributed nationwide throughout the United States.
Ondansetron is a prescription medication used to prevent nausea and vomiting. Temperature abuse during storage may affect the medication's stability and potency. No illnesses or injuries related to this recall have been reported.
Patients currently taking this medication should contact their pharmacy or healthcare provider to determine whether they may have received affected product and to discuss appropriate next steps.
The recalled product
- Product
- ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)
- Brand
- ONDANSETRON HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Prescription / Antiemetic
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 130 products in this recall →Related recalls
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