Home / Recalls / Premier Dental Products Co / D-0490-2026

D-0490-2026 Class III Ongoing

Recalled by Premier Dental Products Co — Plymouth Meeting, PA

Recall Details

Product Type: Drugs
Report Date: April 29, 2026
Initiation Date: April 14, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 573 cartons

Product Description

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.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 640911253, Exp Date. 09/14/2027.