FDA Drugs recall ·
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only… recall
- Recall number
- D-0490-2026
- Date
- (initiated April 14, 2026)
- Company / brand
- Premier Dental Products Co
1710 Romano Dr, Plymouth Meeting, PA, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 573 cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 640911253, Exp Date. 09/14/2027.
Distribution
Nationwide within the United States
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0490-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.