Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviations: Temperature abuse
Aprepitant Capsule, USP, 40 mg, 1 capsule per unit dose package, Rx only, MFG: Sandoz Pharma, NDC 0781-2321-06
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of particulate matter: potential presence of metal particulates in the product.
Reason Lack of Sterility Assurance: Aseptic process simulation failure.
Reason Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium…
Reason Lack of Assurance of Sterility
Reason Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
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