Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
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 Superpotent Drug
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