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Recall Observatory FDA recall evidence

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.

D-0490-2026

April 14, 2026

Class III

Product summary

Firm
Premier Dental Products Co
Event
Event 98775
Status
Ongoing
Classification
Class III
Quantity
573 cartons
Official record key
drug-enforcement:D-0490-2026

Official wording

Reason: 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.

Code information: Lot #: 640911253, Exp Date. 09/14/2027.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing