March 2019 FDA Recall Drug by Pfizer Inc.
D-1073-2019 - Presence of Particulate Matter; glass particulates

This Class I drug recall was voluntarily initiated by Pfizer Inc. on March 15, 2019 for the product Drug. The FDA reported the reason for recall as presence of particulate matter; glass particulates. The product was distributed in United States and Puerto Rico and the recall is currently terminated.

Recall Number: D-1073-2019

Reason for Recall
Presence of Particulate Matter; glass particulates
Initiated
03-15-2019
Reported
04-10-2019
Quantity
283,400 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82362
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-27-2021
Product Description About Product Description
Full technical description of the product.
8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02

Batch or Lot Expiration Information

Lot# Lots: 79-238-EV Exp. 1 July 2019; 79-240-EV Exp. 1 July 2019; 80-088-EV Exp. 1 August 2019