Drug recall D-0490-2026

Class III Ongoing reported Apr 29, 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

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