The Recall Desk
HighFDA (Drugs)·D-1118-2022·Announced 2022-06-15

Cefazolin Sodium Injectable Recalled Nationwide for Temperature Abuse

McKesson Medical-Surgical recalled Cefazolin Sodium injectable (39 cases nationwide) due to temperature abuse during manufacturing that may compromise product sterility.

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 temperature abuse of a sterile injectable pharmaceutical product. Temperature deviation is a risk-of-harm situation that could compromise product sterility and integrity. No illnesses or injuries have been reported in the source material.

Plain-English summary

McKesson Medical-Surgical Inc. has recalled Cefazolin Sodium for injection USP (2g, 50mL duplex container) manufactured by B. Braun Medical Inc. The recall involves 39 cases distributed nationwide in the United States.

The recall was initiated due to cGMP deviations involving temperature abuse during manufacturing. Temperature exposure of a sterile injectable product may compromise product sterility and integrity.

McKesson Medical-Surgical reports that it cannot identify the specific lot numbers received by individual customers. Each recall notification letter includes the distribution date and dates when affected product may have been shipped to the customer.

Healthcare facilities that received this product should consult the information provided in their recall notification letter for details on affected shipments.

The recalled product

Product
CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
Brand
CEFAZOLIN SODIUM
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Sterile Injectables
Hazard
  • cGMP-deviation
  • temperature-abuse
  • sterility-risk

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · CEFAZOLIN SODIUM

Same category