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
Product summary
- 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
Labeling: Incorrect or Missing