Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: DESMOPRESSIN ACETATE, Tablet 0.1 mg may have potentially been mislabeled as the following drug: LOXAPINE, Capsule, 5 mg, NDC 00591036901, Pedigree: AD46426_7, EXP: 5/15/2014.
DESMOPRESSIN ACETATE, Tablet 0.1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591246401.
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…
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