Ferric Subsulfate Recall: Premier Monsel's Solution
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot #: 640911253, Exp Date. 09/14/2027. |
|---|---|
| Lot / date codes | Lot #: 640911253, Exp Date. 09/14/2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.