FDA recall D-0490-2026

Premier Dental Products Co · Class III · drug

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 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.

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2026-04-14
Report date
2026-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plymouth Meeting, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0490-2026