Cefazolin Sodium injection recalled due to temperature abuse during manufacturing
McKesson Medical-Surgical is recalling 26 cases of Cefazolin Sodium injection due to manufacturing deviations involving temperature abuse. The product was distributed nationwide.
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: This FDA Class II recall involves documented manufacturing deviations (temperature abuse) affecting an injectable antibiotic. While no illnesses or injuries have been reported, the manufacturing defect poses a risk of harm to drug safety and efficacy, supporting a Score 3 classification as a risk-of-harm product without reported injury.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Cefazolin Sodium for injection USP in 1G, 50 mL duplex containers (manufactured by B. Braun Medical Inc., NDC 0264-3103-11). The recall affects 26 cases that were distributed nationwide in the United States.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse. Specific lot numbers could not be identified by McKesson for individual consignees; customers have been sent letters with distribution dates and information about affected product.
Healthcare providers who received this product should contact McKesson Medical-Surgical for guidance on returned product and replacement supplies.
The recalled product
- Product
- CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
- Brand
- CEFAZOLIN SODIUM
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Antibiotic
- Hazard
- temperature-abuse
- manufacturing-defect
Distribution
Distributed nationwide across the United States.
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