Reported Apr 29, 2026 · Ongoing
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710…
Premier Dental Products Co.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Premier Dental Products Co · 1710 Romano Dr · Plymouth Meeting, PA · 19462-2822
Is this the product you have?
- Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only
- Manufacturer
Premier Medical Products1710 Romano DrivePlymouth MeetingPA 19462NDC 48783-112-08
- Lot codes and dates
Lot #: 640911253Exp Date. 09/14/2027
- Amount recalled
- 573 cartons
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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