Multi-event September 2013 FDA Recall Metoclopramide by Hospira Inc.
This Multi-event Class II drug recall was voluntarily initiated by Hospira Inc. on September 24, 2013 for the product Metoclopramide. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-012-2014
Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
09-24-2013
11-27-2013
251,400 vials
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 and Puerto Rico
10-06-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01
Batch or Lot Expiration Information
Lot# : 28-104-DK*, Exp 10/01/2014 (* lot number may be proceeded with an 01)
Affected Packages Involved in this Recall
Recall Number: D-013-2014
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
09-24-2013
11-27-2013
681,400 vials
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 and Puerto Rico
10-06-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03
Batch or Lot Expiration Information
Lot# 29-484-DK* and 29-510-DK* Exp 05/01/2015 (lot number may be proceeded with an 01)
