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.
FDA recall notice · announced May 23, 2018 · Pharmalucence
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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.
Reason for recall
Failed Stability Specifications
Notes
Distribution: US Nationwide
Lot/code information: Part Number MEM05 and MEB30 both with expiry date 12/2018
Quantity: 157 units (5 count) and 464 units (30 count)
Status: Terminated
Products in this recall event:
- 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. (D-0815-2018)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.