Desmopressin Nasal Spray
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Class I — High risk. Reasonable probability of serious harm or death.
Superpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0
Compare with the code on your package — it is the most precise check available.
Drug: Desmopressin Category: Allergy & Cold Medication
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Subpotent Drug
CGMP Deviations
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.
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
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