⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Premier Dental Products Co: Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Me

DrugsSource: FDA (drug) · Date: 2026-04-29

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / 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 / hazard
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.
Classification
Class III
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2026-04-14
Code info
Lot #: 640911253, Exp Date. 09/14/2027.
Product quantity
573 cartons
Voluntary mandated
Voluntary: Firm initiated
City
Plymouth Meeting
State
PA
Country
United States
Event id
98775
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