Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40
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 cGMP deviations: Temperature abuse
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
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