Kit for the Preparation of Technetium TC-99M Mebrofenin — Class II drug recall D-0815-2018
Terminated recall by Pharmalucence, Inc., reported 2018-05-23, distributed nationwide. Failed Stability Specifications
| Recall number | D-0815-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmalucence, Inc., Billerica, MA, United States |
| Recall initiated | 2018-04-10 |
| Classified | 2018-05-15 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2018-10-31 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 45567-0455, 45567-0455-01, 45567-0455-02 |
| Model numbers | MEB30, MEM05 |
| Expiration dates | 2018-12 |
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
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-0815-2018. 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.