September 2017 FDA Recall Drug by Pfizer Inc.
D-1177-2017 - Non-Sterility

This Class II drug recall was voluntarily initiated by Pfizer Inc. on September 1, 2017 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1177-2017

Reason for Recall
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Initiated
09-01-2017
Reported
10-04-2017
Quantity
18,725 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78048
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pfizer Inc.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-24-2020
Product Description About Product Description
Full technical description of the product.
Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24

Batch or Lot Expiration Information

Lot# Lot: 63-075-DK Exp. FEB 2019