Home / Recalls / Pharmalucence, Inc. / D-1040-2018

D-1040-2018 Class II Terminated

Recalled by Pharmalucence, Inc. — Billerica, MA

Recall Details

Product Type
Drugs
Report Date
August 15, 2018
Initiation Date
June 6, 2018
Termination Date
March 11, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
95 kits

Product Description

Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.

Reason for Recall

Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.

Distribution Pattern

Nationwide

Code Information

Lot 4223

Other recalls by Pharmalucence, Inc.

  • D-0815-2018 Class II — Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count (April 10, 2018)
  • D-808-2013 Class III — Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection f (May 30, 2013)