April 2018 FDA Recall Kit For The Preparation Of Technetium Tc 99m Mebrofenin by Pharmalucence, Inc.
D-0815-2018 - Failed Stability Specifications

This Class II drug recall was voluntarily initiated by Pharmalucence, Inc. on April 10, 2018 for the product Kit For The Preparation Of Technetium Tc 99m Mebrofenin. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0815-2018

Reason for Recall
Failed Stability Specifications
Initiated
04-10-2018
Reported
05-23-2018
Quantity
157 units (5 count) and 464 units (30 count)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79802
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.
Pharmalucence, 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.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-31-2018
Product Description About Product Description
Full technical description of the product.
Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.

Batch or Lot Expiration Information

Lot# Part Number MEM05 and MEB30 both with expiry date 12/2018

Affected Packages Involved in this Recall

45567-0455-1 Kit For The Preparation Of Technetium Tc 99m Mebrofenin
45567-0455-2 Kit For The Preparation Of Technetium Tc 99m Mebrofenin