August 2018 FDA Recall Drug by Pfizer Inc.
D-1184-2018 - Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point

This Class III drug recall was voluntarily initiated by Pfizer Inc. on August 28, 2018 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; out of specification stability testing results at the 18 month time point. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1184-2018

Reason for Recall
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Initiated
08-28-2018
Reported
09-19-2018
Quantity
1,580 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80923
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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 USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-26-2020
Product Description About Product Description
Full technical description of the product.
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01

Batch or Lot Expiration Information

Lot# Lot: DP602, 10/2018