FDA Drug recall D-0815-2018
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 . Manu…
- FDA Drug
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of 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 . Manu… by Pharmalucence, citing failed Stability Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0815-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-10 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pharmalucence |
| Distribution | US |
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
Failed Stability Specifications
Identifiers
| ndc | 45567-0455-1 |
|---|---|
| ndc | 45567-0455-2 |
| code_info | Part Number MEM05 and MEB30 both with expiry date 12/2018 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0815-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.