Recall
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.
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.

View original FDA notice →

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