FDAFDA · Food and drugs·Recall number 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 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.
Published May 23, 2018 · Recall initiated: April 10, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN
- Manufacturer
- Pharmalucence, Inc.
- Distributor
- US Nationwide
- Lot
- Part Number MEM05 and MEB30 both with expiry date 12/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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