March 2016 FDA Recall Drug by Hospira Inc.
D-1137-2016 - Presence of Particulate Matter
This Class I drug recall was voluntarily initiated by Hospira Inc. on March 23, 2016 for the product Drug. 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-1137-2016
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
03-23-2016
07-13-2016
88,500 vials
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, United Arab Emirates, Kuwait, and Bahrain
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
Batch or Lot Expiration Information
Lot# : 50-343-DK*, Exp 01FEB2017; note that the lot number may be followed by numbers from 01 to 99.
