Why it was recalled
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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 640911253, Exp Date. 09/14/2027.
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0490-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Apr 14, 2026
- FDA report date
- Apr 29, 2026
- Quantity
- 573 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Premier Dental Products Co
Original FDA data
Every field from FDA enforcement report D-0490-2026, exactly as published.
Show all FDA fields
- City
- Plymouth Meeting
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 98775
- Address
- 1710 Romano Dr
- Code information
- Lot #: 640911253, Exp Date. 09/14/2027.
- Postal code
- 19462-2822
- Report date
- Apr 29, 2026
- Product type
- Drugs
- Recall number
- D-0490-2026
- Classification
- Class III
- Recalling firm
- Premier Dental Products Co
- Product quantity
- 573 cartons
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Apr 14, 2026
- Initial firm notification
- Center classification date
- Apr 24, 2026