# FDA recall D-0490-2026

> **Premier Dental Products Co** · Class III · drug recall initiated 2026-04-14.

## 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 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

## Key facts

- **Recall number:** D-0490-2026
- **Recalling firm:** Premier Dental Products Co
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-14
- **Report date:** 2026-04-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth Meeting, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0490-2026

## Citation

> AI Analytics. FDA recall D-0490-2026. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0490-2026. Source: US FDA. Licensed CC0.

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