FDAHealthApril 14, 2026
Premier Dental Products Co — 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-
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 14, 2026
Nationwide within the United States
What's affected?
- 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.
- Brand
- MONSELS SOLUTION
- Lot code
- 640911253
Additional details
Lot #: 640911253, Exp Date. 09/14/2027.
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 573 cartons.
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