Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Roman
Summary
The FDA issued a Class III for Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufactur by Premier Dental Products Co. 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 (202.
Details
Source
Drug Recall
External ID
D-0490-2026
Action Date
2026-04-29
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot #: 640911253, Exp Date. 09/14/2027.
Quantity Affected: 573 cartons
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
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-14
Company
Plymouth Meeting, PA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 82 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Premier Dental Products Co has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Premier Dental Products Co) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Premier Dental Products Co have FDA actions?
Premier Dental Products Co has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0490-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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