Desmopressin Acetate Tablet
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0
Compare with the code on your package — it is the most precise check available.
Drug: Desmopressin Category: Allergy & Cold Medication
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Desmopressin Acetate NDC 60505-0815 |
TRIHYDRATE 10 ug/1 | Spray Nasal |
Apotex Corp. | Rx |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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.
Superpotent Drug
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Lack of Assurance of Sterility
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
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