Drug 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.
D-0815-2018
Product summary
- Event
- Event 79802
- Status
- Terminated
- Classification
- Class II
- Quantity
- 157 units (5 count) and 464 units (30 count)
- Official record key
drug-enforcement:D-0815-2018
Official wording
Reason: Failed Stability Specifications
Code information: Part Number MEM05 and MEB30 both with expiry date 12/2018
Distribution pattern: US Nationwide
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications