Injectable Ampicillin recalled nationwide due to manufacturing temperature control deviations
McKesson Medical-Surgical is recalling Ampicillin for Injection nationwide due to cGMP deviations involving temperature abuse during manufacturing that may have compromised drug quality.
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: FDA Class II classification with manufacturing deviations affecting an injectable medication represents significant quality concerns. Temperature abuse may compromise drug sterility and potency, making this a risk-of-harm product as defined in the severity rubric.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Ampicillin (Ampicillin Sodium) for Injection, 1 gram per vial, 10-count boxes, distributed nationwide. The recall is due to cGMP deviations, specifically temperature abuse during manufacturing that may have affected product quality.
The product was distributed throughout the United States. While McKesson cannot pinpoint the exact lot numbers received by individual healthcare facilities, each facility that received affected shipments has been notified with distribution and shipment dates to help identify potentially impacted inventory.
Healthcare providers and patients with questions about this recall should contact McKesson Medical-Surgical directly for information about specific lots and recommended actions. Affected facilities should coordinate with the manufacturer regarding proper handling of recalled product.
The recalled product
- Product
- AMPICILLIN (AMPICILLIN SODIUM)
- Brand
- AMPICILLIN
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Antibiotic
- Hazard
- temperature-abuse
- cGMP-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (4)
- 0355150113101
- 0355150111107
- 0355150114207
- 0355150112104
Distribution
Distributed nationwide across the United States.
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