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.

FDA recall notice · announced August 15, 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 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.

Reason for recall

Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.

Notes

Distribution: Nationwide
Lot/code information: Lot 4223
Quantity: 95 kits
Status: Terminated
Products in this recall event:
- 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, I (D-1040-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.