Drug recall D-0490-2026
Product
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Lots and codes
Lot #: 640911253, Exp Date. 09/14/2027.
Recall details
- Recalling firm
- Premier Dental Products Co, Plymouth Meeting, PA
- Quantity
- 573 cartons
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 14, 2026
Related products
- Monsels Solution – drug information
- NDC 48783-112 Monsels Solution · Ferric Subsulfate 210 mg/g · Premier Dental Products Company