October 2016 FDA Recall Ceftriaxone Sodium by Sandoz Inc
D-0145-2017 - Labeling
This Class III drug recall was voluntarily initiated by Sandoz Inc on October 19, 2016 for the product Ceftriaxone Sodium. The FDA reported the reason for recall as labeling. The product was distributed in WI and the recall is currently terminated.
Recall Number: D-0145-2017
Labeling: Missing Label
10-19-2016
11-30-2016
139,430 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Sandoz Inc
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.
WI
07-27-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01
Batch or Lot Expiration Information
Lot# Sandoz - Lot GJ7151(Pfizer- Lot 670028M); Exp. 07/19
