Desmopressin Nasal Spray
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.
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
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.
Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00.
Compare with the code on your package — it is the most precise check available.
Drug: Desmopressin
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 23155-0490 |
.2 mg/1 | Tablet Oral |
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 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. 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
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
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
CGMP Deviations
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
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