Pharmalucence, Inc. recalls Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC…
- Recall date
- April 10, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0815-2018
- FDA classification
- Class II
- Brand / firm
- Pharmalucence, Inc.
- Sold / distributed
- US Nationwide
Why it was recalled
Failed Stability Specifications
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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