FDA DrugsClass II
Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, M...
Published: April 22, 2026Recall ID: D-0510-2026Category: drugsCountry: US
Reason for Recall / Hazard
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Weston |
| State | FL |
| Openfda › Unii | XB13HYU18U |
| Openfda › Route | NASAL |
| Openfda › Rxcui | 849506 |
| Openfda › Spl id | f90935bd-bb23-2f9c-3271-8508e92d45c4 |
| Openfda › Brand name | DESMOPRESSIN ACETATE |
| Openfda › Spl set id | 1ac423b8-27a6-4cef-4a82-c50bf81b4f49 |
| Openfda › Package ndc | 60505-0815-0 |
| Openfda › Product ndc | 60505-0815 |
| Openfda › Generic name | DESMOPRESSIN ACETATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DESMOPRESSIN ACETATE |
| Openfda › Manufacturer name | Apotex Corp. |
| Openfda › Application number | ANDA076703 |
| Openfda › Is original packager | true |
| Event id | 98736 |
| Address 1 | 2400 N Commerce Pkwy Ste 400 |
| Address 2 | N/A |
| Code info | Lot #: VM4231, Exp 06/30/2027 |
| Postal code | 33326-3253 |
| Report date | 20260422 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260408 |
| Initial firm notification | |
| Center classification date | 20260501 |
Overview
- Recalling FirmApotex Corp.
- StatusOngoing
- Risk LevelClass II
- DistributionU.S.A. Nationwide