Monsel's Solution ferric subsulfate vials recalled for incorrect expiration date printing
Premier Dental Products is recalling Monsel's Solution (ferric subsulfate) 8 mL vials because the expiration date on the vial itself is printed with an extra digit (2709114 instead of 270914). The carton expiration date is correct.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall involving a labeling error (incorrect printing of the expiration date on the vial). The source text explicitly states the error is limited to the vial label only; the correct expiration date is printed on the carton. No health consequences are reported or implied. Per the rubric, Class III recalls are typically scored 1 or 2 as they are by definition unlikely to cause adverse health consequences.
Plain-English summary
Premier Dental Products Co is recalling Monsel's Solution (ferric subsulfate) 8 mL bottles, NDC 48783-112-08, lot #640911253 with expiration date 09/14/2027. The expiration date printed on the vial itself contains an extra digit and reads 2709114 instead of the correct date 270914 (2027-09-14).
This labeling error is limited to the vial itself; the outer carton box of 12 bottles has the correct expiration date printed. The recall affects 573 cartons distributed nationwide within the United States.
Patients and healthcare providers using this product should verify the correct expiration date (2027-09-14) on the outer carton box rather than relying on the vial label. Prescribers and patients should contact Premier Dental Products Co or the FDA with questions about the recall.
The recalled product
- Product
- MONSELS SOLUTION (FERRIC SUBSULFATE)
- Brand
- MONSELS SOLUTION
- Manufacturer
- Premier Dental Products Co
- Category
- Drug — Topical / Dental
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 640911253
- Exp Date. 09/14/2027.
Distribution
Distributed nationwide across the United States.