April 2017 FDA Recall Dextrose by Hospira Inc.
D-0862-2017 - Presence of Particulate Matter
This Class I drug recall was voluntarily initiated by Hospira Inc. on April 21, 2017 for the product Dextrose. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0862-2017
Presence of Particulate Matter: human hair found within an internal sample syringe.
04-21-2017
05-31-2017
71,550 syringes
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10
Batch or Lot Expiration Information
Lot# Lot 58382EV*, Exp 1OCT 2017, *lot may be followed by 01 or 02
