The Recall Desk
HighFDA (Drugs)·D-1103-2022·Announced 2022-06-15

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.

What this means for you

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
Hazard
  • temperature-abuse
  • stability-concern

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · ONDANSETRON HYDROCHLORIDE

Same category