Olanzapine vials recalled nationwide due to temperature exposure
McKesson Medical-Surgical is recalling Olanzapine 10 mg single-dose vials manufactured by Auromedics due to temperature abuse during distribution. Affected patients should contact their pharmacy or healthcare provider.
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 due to GMP deviations affecting drug stability. The source reports no illnesses or injuries, and the hazard is theoretical—potential loss of efficacy from temperature exposure. Per the rubric, Class II without reported illnesses and theoretical hazard scores at most 3.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Olanzapine 10 mg single-dose vials (NDC# 55150-0308-01) manufactured by Auromedics Pharma LLC. The recall affects product distributed nationwide in the USA due to temperature abuse, which represents a deviation from manufacturing standards (cGMP).
Temperature exposure during storage or distribution may affect the stability and efficacy of the medication. Because McKesson cannot identify specific lot numbers for individual consignees, all affected product should be considered potentially compromised. Patients currently taking recalled vials should discontinue use and contact their pharmacy or healthcare provider for guidance on obtaining replacement medication.
Healthcare providers and pharmacists should check their inventory against the distribution dates provided in recall notifications and remove affected product from use. Patients should not use any recalled vials and should consult with their healthcare provider before making any changes to their medication.
The recalled product
- Product
- Olanzapine single dose vial Lyophilized, 10 mg, Rx only, MFG: Auromedics Pharma LLC, NDC# 55150-0308-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Antipsychotic Injectable
- Hazard
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.
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