FDAFDA · Food and drugs·Recall number D-1040-2018
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.
Published August 15, 2018 · Recall initiated: June 6, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Brand
- KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE
- Manufacturer
- Pharmalucence, Inc.
- Distributor
- Nationwide
- Lot
- Lot 4223
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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