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FDA (Drug enforcement)Recalled 2026-04-14class iii

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 48783-112-0

Hazard

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.

Details from the source

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: Nationwide within the United States Quantity: 573 cartons Lot/code info: Lot #: 640911253, Exp Date. 09/14/2027.

Source

Official record: FDA (Drug enforcement)

Republished from the official source above; details can change — the source record controls.

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