The Recall Desk
ModerateFDA (Drugs)·D-0997-2022·Announced 2022-06-15

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.

What this means for you

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
Hazard
  • temperature-abuse
  • manufacturing-deviation

Distribution

Distributed nationwide across the United States.

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