June 2018 FDA Recall Drug by Pfizer
D-1023-2018 - Microbial Contamination of Sterile Products

This Class II drug recall was voluntarily initiated by Pfizer on June 28, 2018 for the product Drug. The FDA reported the reason for recall as microbial contamination of sterile products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1023-2018

Reason for Recall
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Initiated
06-28-2018
Reported
08-08-2018
Quantity
234,680 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80399
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
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.
Nationwide in the USA and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-25-2022
Product Description About Product Description
Full technical description of the product.
Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.

Batch or Lot Expiration Information

Lot# : 712453A, Exp 1-Nov-18; 771803A, Exp 1-May-19; 792103A, Exp 1-Jul-19; 800903A, Exp 1-Aug-19; 810853A, Exp 1-Sep-19; 841703A, 841753A, Exp 1-Dec-19; 850553A, Exp 1-Jan-20.