Premier Dental Products Co recalls Premier
- Recalling company
- Premier Dental Products Co
- 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
- 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.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Apr 14, 2026
- Reported
- Apr 29, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- 573 cartons
- Lot / codes
- Lot #: 640911253, Exp Date. 09/14/2027.
- Company location
- Plymouth Meeting, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0490-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0490-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.