Premier Dental Products Co recalls Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Roma…

Recall date

April 14, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0490-2026

FDA classification

Class III

Brand / firm

Premier Dental Products Co

Sold / distributed

Nationwide within the United States

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.