FDA Drug recall D-0490-2026
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth M…
- FDA Drug
- Class III
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class III recall of Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth M… by Premier Dental Products, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0490-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-04-14 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Premier Dental Products |
| Distribution | US |
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.
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.
Identifiers
| ndc | 48783-112-08 |
|---|---|
| code_info | Lot #: 640911253, Exp Date. 09/14/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0490-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.