June 2018 FDA Recall Naloxone Hydrochloride by Hospira Inc, Lake Forest
D-0906-2018 - Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.

This Class I drug recall was voluntarily initiated by Hospira Inc, Lake Forest on June 4, 2018 for the product Naloxone Hydrochloride. The FDA reported the reason for recall as presence of particulate matter; potential for particulate matter on the syringe plunger.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0906-2018

Reason for Recall
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Initiated
06-04-2018
Reported
06-13-2018
Quantity
164,860 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80167
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
HOSPIRA INC, LAKE FOREST
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S., Puerto Rico, and Guam
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-27-2020
Product Description About Product Description
Full technical description of the product.
Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL

Batch or Lot Expiration Information

Lot# 72680LL, Exp. 1DEC2018 (NDC 0409-1782-03); 76510LL, Exp. 1APR2019 (NDC 0409-1782-69)

Affected Packages Involved in this Recall

0409-1782-03 Naloxone Hydrochloride
0409-1782-69 Naloxone Hydrochloride