FDA-Drug2018-08-15Class II
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.
Pharmalucence, Inc.
Hazard
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Sold states
Nationwide
Affected count
95 kits
Manufactured in
29 Dunham Rd, N/A, Billerica, MA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1040-2018Don't want to check this manually?
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