FDAFDA · Food and drugs·Recall number D-0490-2026
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.
Published April 29, 2026 · Recall initiated: April 14, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- MONSELS SOLUTION
- Manufacturer
- Premier Dental Products Co
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 640911253, Exp Date. 09/14/2027.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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