Drug recall D-0815-2018
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
Lots and codes
Part Number MEM05 and MEB30 both with expiry date 12/2018
Recall details
- Recalling firm
- Pharmalucence, Inc., Billerica, MA
- Quantity
- 157 units (5 count) and 464 units (30 count)
- Distribution
- US Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 10, 2018
- Terminated
- October 31, 2018
Related products
- Kit for the Preparation of Technetium Tc 99m Mebrofenin – drug information
- NDC 45567-0455 Kit for the Preparation of Technetium Tc 99m Mebrofenin · Mebrofenin 45 mg/10mL · Sun Pharmaceutical Industries, Inc.