December 2016 FDA Recall Midazolam by Fresenius Kabi Usa, Llc
D-0456-2017 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on December 16, 2016 for the product Midazolam. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0456-2017
Failed Impurities/Degradation Specifications
12-16-2016
02-08-2017
47, 020 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.
Nationwide and Puerto Rico
06-22-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
Batch or Lot Expiration Information
Lot# Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017
