Kit for the Preparation of Technetium Tc99m Medronate — Class II drug recall D-1040-2018
Terminated recall by Pharmalucence, Inc., reported 2018-08-15, distributed nationwide. Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
| Recall number | D-1040-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmalucence, Inc., Billerica, MA, United States |
| Recall initiated | 2018-06-06 |
| Classified | 2018-08-03 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2019-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 95 kits |
| Reason classes | sterility |
| NDC | 45567-0040, 45567-0040-01, 45567-0040-02 |
| Lot numbers | 4223 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1040-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.