FDA Recall D-0490-2026

Premier Dental Products Co · Plymouth Meeting, PA

Class III Ongoing 30 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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.

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

Quantity: 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.

Recall record

Recall number: D-0490-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide within the United States
Recall initiated: 2026-04-14
Classified by FDA Center: 2026-04-24
FDA published: 2026-04-29
Recalling firm: Premier Dental Products Co
Firm location: Plymouth Meeting, PA

Drug identification

Brand name(s): MONSELS SOLUTION
Generic name(s): FERRIC SUBSULFATE
Manufacturer(s): Premier Dental Products Company
NDC(s): 48783-112
Route(s): TOPICAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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