Home / Recalls / Pharmalucence, Inc. / D-0815-2018

D-0815-2018 Class II Terminated

Recalled by Pharmalucence, Inc. — Billerica, MA

Recall Details

Product Type
Drugs
Report Date
May 23, 2018
Initiation Date
April 10, 2018
Termination Date
October 31, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
157 units (5 count) and 464 units (30 count)

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.

Reason for Recall

Failed Stability Specifications

Distribution Pattern

US Nationwide

Code Information

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

Other recalls by Pharmalucence, Inc.

  • D-1040-2018 Class II — Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packa (June 6, 2018)
  • D-808-2013 Class III — Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection f (May 30, 2013)