May 2017 FDA Recall Drug by Lantheus Mi Radipharmaceuticals Inc.
D-0942-2017 - Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent

This Class III drug recall was voluntarily initiated by Lantheus Mi Radipharmaceuticals Inc. on May 18, 2017 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; out of specification result for acetonitrile residual solvent. The product was distributed in Puerto Rico and the recall is currently terminated.

Recall Number: D-0942-2017

Reason for Recall
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Initiated
05-18-2017
Reported
07-12-2017
Quantity
26 doses

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77433
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.
Lantheus MI Radipharmaceuticals 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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2017
Product Description About Product Description
Full technical description of the product.
Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01

Batch or Lot Expiration Information

Lot# Lot: FDG170518-01, exp 5/18/2017