Desmopressin Nasal Spray
Reason Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
GMP Deviations: Product bottle may be absent of desiccant.
Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-604-11
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 Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Reason Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Reason Subpotent Drug
Reason CGMP Deviations
Reason Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
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