April 2012 FDA Recall Drug by Hospira Inc.
D-1419-2012 - Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
This Class I drug recall was voluntarily initiated by Hospira Inc. on April 17, 2012 for the product Drug. The FDA reported the reason for recall as superpotent; cartridges labeled to contain 1 ml found to contain 2.2 ml. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1419-2012
Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
04-17-2012
07-25-2012
212,370 cartidges
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.
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
05-29-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30
Batch or Lot Expiration Information
Lot# 10830LL, Exp. 1APR2013
