# FDA recall D-0775-2023

> **Denison Pharmaceuticals, LLC** · Class II · drug recall initiated 2023-05-03.

## Product

Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.

## Reason for recall

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

## Distribution

Product was distributed Nationwide.

## Key facts

- **Recall number:** D-0775-2023
- **Recalling firm:** Denison Pharmaceuticals, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-05-03
- **Report date:** 2023-06-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lincoln, RI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0775-2023

## Citation

> AI Analytics. FDA recall D-0775-2023. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0775-2023. Source: US FDA. Licensed CC0.

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