Class II · Moderate risk Terminated
Ampicillin 8gm in Ns 400ml
Reason Lack of sterility assurance
Is Ampicillin recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Ampicillin (36 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ampicillin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class II · Moderate risk Terminated
Ampicillin 12gm in Ns 600m
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Unasyn
Reason Presence of Particulate Matter: particulate matter identified after reconstitution.
Class I · High risk Terminated
Ampicillin and Sulbactam for Injection
Reason Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Class I · High risk Terminated
Ampicillin and Sulbactam for Injection 1.5 g vial
Reason Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Class III · Low risk Terminated
Ampicillin for Injection
Reason Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Class II · Moderate risk Terminated
Ampicillin/Sulbactam 12GM in NS
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class III · Low risk Terminated
Ampicillin Capsules
Reason Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Class II · Moderate risk Ongoing
Unasyn
Reason Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
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