April 2023 FDA Recall Calcitonin Salmon by Apotex Corp.
D-0568-2023 - Presence of Foreign Substance
This Class II drug recall was voluntarily initiated by Apotex Corp. on April 26, 2023 for the product Calcitonin Salmon. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0568-2023
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
04-26-2023
05-17-2023
82,375 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Apotex Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide throughout the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : TH5645, Exp. 01/2025
