Ferric Subsulfate Recall: Premier Monsel's Solution
Announced 2026-04-29 · FDA
The FDA recall involves Premier Dental Products Co.'s Premier Monsel's Ferric Subsulfate Solution, 8 mL bottles, Rx only. The expiration date on the vial is printed as 2709114 instead of 270914 (2027-09-14). The issue is limited to the vial; the saleable box of 12 bottles has the correct expiration date. The recall covers 573 cartons distributed nationwide; Lot 640911253 expires 09/14/2027.
| Brand | 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. |
| Severity | low |
| Units affected | 573 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
| Recall / campaign no. | Lot #: 640911253, Exp Date. 09/14/2027. |
WHAT YOU SHOULD DO
- Do not use any affected 8 mL vials with the incorrect expiration date.
- Contact Premier Dental Products Co. for guidance and possible replacement, and reference lot 640911253 and Exp 09/14/2027.
- If you have used the product or have concerns, consult your dentist or healthcare provider.
- Keep the packaging and related documentation until you receive further instructions.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.