September 2021 FDA Recall Morphine Sulfate by Fresenius Kabi Usa Llc
D-0856-2021 - Defective container
This Class II drug recall was voluntarily initiated by Fresenius Kabi Usa Llc on September 17, 2021 for the product Morphine Sulfate. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0856-2021
Defective container: Cracked vials leading to lack of sterility assurance
09-17-2021
10-06-2021
963000 vials
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Kabi USA LLC
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.
U.S.A. Nationwide
06-20-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper
Batch or Lot Expiration Information
Lot# 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023
