Calcitonin Salmon Spray, Metered
FDA Recall NDC 60505-0823
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Calcitonin Salmon (NDC 60505-0823). A significant event, classified as Class II, was initiated on Apr 26, 2023 by Apotex Corp.. The reported reason for this action was: "Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Apr 26, 2023
May 17, 2023
82,375 bottles
Recall Profile & Regulatory Data
Event ID
92208
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide throughout the United States
Product Description
Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Corp., Toronto, Ontario, Canada, M9L 1T9, NDC 60505-0823-6
Batch or Lot Expiration Information
Lot# : TH5645, Exp. 01/2025
Affected Packages Involved in this Recall
60505-0823-0Product
60505-0823-6Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
