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.
USPremier, 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.
Recalling Firm: Premier Dental Products Co
Reason for Recall / Hazard
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.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Plymouth Meeting |
| State | PA |
| Openfda › Unii | 3QJ8WS6V8H |
| Openfda › Route | TOPICAL |
| Openfda › Spl id | 4847c0c4-f60a-2f71-e063-6294a90a5830 |
| Openfda › Brand name | MONSELS SOLUTION |
| Openfda › Spl set id | 7a9923af-b8ed-4dc5-b6ae-2f42f83eb3db |
| Openfda › Package ndc | 48783-112-08 |
| Openfda › Product ndc | 48783-112 |
| Openfda › Generic name | FERRIC SUBSULFATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | FERRIC SUBSULFATE |
| Openfda › Manufacturer name | Premier Dental Products Company |
| Openfda › Is original packager | true |
| Event id | 98775 |
| Address 1 | 1710 Romano Dr |
| Address 2 | N/A |
| Code info | Lot #: 640911253, Exp Date. 09/14/2027. |
| Postal code | 19462-2822 |
| Report date | 20260429 |
| Product type | Drugs |
| Product 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260414 |
| Initial firm notification | |
| Center classification date | 20260424 |
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Overview
- Recalling FirmPremier Dental Products Co
- StatusOngoing
- Risk LevelClass III
- DistributionNationwide within the United States
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🚨 SAFETY ALERT: Premier Dental Products Co - 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. Check if your household is affected: https://therecallfile.com/recalls/premier-monsel-s-ferric-subsulfate-solution-8-ml-bottles-rx-only-manuf/FDA-D-0490-2026
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