# FDA recall D-0147-2025

> **Keystone Industries** · Class II · drug recall initiated 2024-11-14.

## Product

Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.

## Reason for recall

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

## Distribution

Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

## Key facts

- **Recall number:** D-0147-2025
- **Recalling firm:** Keystone Industries
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-11-14
- **Report date:** 2024-12-25
- **Termination date:** 2026-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gibbstown, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0147-2025

## Citation

> AI Analytics. FDA recall D-0147-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0147-2025. Source: US FDA. Licensed CC0.

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