Recall: D-0568-2023

Class II - Potentially Harmful

Class IIClassification

2023-04-26Initiated

CompletedStatus

Apotex Corp.Firm

Product

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

Reason

Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.

Distribution

Nationwide throughout the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.