United StatesPremier Monsel's Ferric Subsulfate Solution, 8 mL bottles (Rx only), NDC 48783-112-08, lot #640911253, Exp. 09/14/2027, sold in cartons of 12 may have the vial expiration misprinted as 2709114 instead of 270914. The product is being recalled for incorrect or missing lot and/or expiration date labeling on the vial; the saleable box of 12 has the correct expiration. 573 cartons were distributed nationwide in the United States.
What's being 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.
Recalling firm: Premier Dental Products Co, Plymouth Meeting, PA, United States.
How to identify it
Lot #: 640911253, Exp Date. 09/14/2027.
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)