Kit For The Preparation Of Technetium Tc 99m Mebrofenin Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 45567-0455
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Kit For The Preparation Of Technetium Tc 99m Mebrofenin (NDC 45567-0455). A significant event, classified as Class II, was initiated on Apr 10, 2018 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Stability Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Stability Specifications
Apr 10, 2018
May 23, 2018
157 units (5 count) and 464 units (30 count)
Recall Profile & Regulatory Data
Event ID
79802
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pharmalucence, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Termination Date
Oct 31, 2018
Product Description
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
45567-0455-1Product
45567-0455-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
