May 2017 FDA Recall Levophed by Hospira Inc., A Pfizer Company
D-0898-2017 - GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
This Class II drug recall was voluntarily initiated by Hospira Inc., A Pfizer Company on May 18, 2017 for the product Levophed. The FDA reported the reason for recall as gmp deviation; a foreign stopper was observed during packaging of a lot of product.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0898-2017
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
05-18-2017
06-21-2017
(720503A): 43,200 vials, (720603A): 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., A Pfizer Company
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, Canada and Singapore
05-02-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04
Batch or Lot Expiration Information
Lot# 720503A, 720603A (Canada only)
