FDAJune 6, 2018drug
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
What to do
FDA enforcement status: Terminated
Brands named
pharmalucence
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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