Plymouth Meeting, PA, United States
Premier Dental Products Co recalls
2 recalls recorded since 2018, most recently on 14 April 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class III Drugs
- Recall started
- 14 April 2026
- 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.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0490-2026
- 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.
Ongoing Class II Medical devices
- Recall started
- 27 February 2025
- Reason
- The hardness not meeting the material specification and may cause the diamond bur to bend.
- Distribution
- US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1408-2025
- Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.