Premier Dental Products Co: Premier, Monsel's, Ferric Subsulfate Solution
Recall Summary Premier Dental Products is recalling Monsel's Ferric Subsulfate Solution (8 mL bottles) nationwide because the expiration date printed on individual vials contains an extra digit, reading "2709114" instead of the correct date "270914" (September 14, 2027). The expiration date on the outer box packaging is printed correctly. This is a prescription-only product distributed across all U.S. states.
- Recalling firm
- 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
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-14
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/78b22103-fab4-4353-8f2b-0ab60fbdc739