August 2013 FDA Recall Drug by Hospira Inc.
D-66201-001 - Presence of Particulate Matter; report of visible particulates in the glass ampule
This Class II drug recall was voluntarily initiated by Hospira Inc. on August 29, 2013 for the product Drug. The FDA reported the reason for recall as presence of particulate matter; report of visible particulates in the glass ampule. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-66201-001
Presence of Particulate Matter; report of visible particulates in the glass ampule
08-29-2013
10-09-2013
86,400 ampuls
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.
Hospira 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.
Nationwide
11-10-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
Batch or Lot Expiration Information
Lot# Lot 23-227-DK
