Monsel's Ferric Subsulfate Solution 8 mL
Premier Dental Products is recalling Monsel's Ferric Subsulfate Solution 8 mL vials (NDC 48783-112-08) due to incorrect expiration date on the vial label.
Stop using affected vials and contact Premier Dental Products Co for replacement product with correct labeling. Verify the expiration date on the vial itself; if it reads 2709114, do not use.
Why it was recalled
Premier Dental Products is recalling Monsel's Ferric Subsulfate Solution, 8 mL bottles (NDC 48783-112-08) due to incorrect expiration date printing on the vial label. The expiration date is printed as 2709114 instead of the correct 270914 (September 14, 2027). The box label has the correct expiration date. Affected vials are in boxes of 12 bottles.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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.
- UPC
- 640911253
- Recall #
- D-0490-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification