Injectable azithromycin vials recalled for manufacturing temperature deviation
McKesson Medical-Surgical is recalling Azithromycin for Injection 500 mg vials nationwide due to temperature control deviations identified during manufacturing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with a manufacturing process deviation, but no reported illnesses, injuries, or deaths have been documented. Temperature abuse during manufacturing represents a quality-control violation rather than an identified safety hazard with demonstrated harm.
Plain-English summary
Azithromycin for Injection USP, 500 mg per vial (NDC 55150-174-10), is being recalled by McKesson Medical-Surgical Inc. due to cGMP deviations involving temperature abuse during manufacturing. The product, manufactured by Auromedics Pharma LLC, was distributed nationwide to healthcare facilities and distributors.
McKesson has notified customers that the particular lot numbers affected cannot be readily identified without information from individual consignees. Each notification letter specifies the date of distribution and the dates when impacted product may have been shipped to customers.
Healthcare providers and pharmacies should verify whether their supplies are affected and contact their pharmaceutical distributor or McKesson Medical-Surgical for instructions regarding this recall.
The recalled product
- Product
- AZITHROMYCIN (AZITHROMYCIN)
- Brand
- AZITHROMYCIN
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Antibiotic
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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