FDAApril 10, 2018drug
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Failed Stability Specifications
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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