FDA-Drug2018-05-23Class II

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.

Pharmalucence, Inc.
Hazard

Failed Stability Specifications

Sold states
US Nationwide
Affected count
157 units (5 count) and 464 units (30 count)
Manufactured in
29 Dunham Rd, Billerica, MA, United States
Products
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 notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0815-2018

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