The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1009-2022·Announced 2022-06-15

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.

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 3/5 (High).

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

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.

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.

See all 130 products in this recall →

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