# FDA recall D-0943-2023

> **Kramer Laboratories, Inc.** · Class II · drug recall initiated 2023-06-23.

## Product

Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807

## Reason for recall

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

## Distribution

nationwide within the United States

## Key facts

- **Recall number:** D-0943-2023
- **Recalling firm:** Kramer Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-06-23
- **Report date:** 2023-08-02
- **Termination date:** 2024-03-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0943-2023

## Citation

> AI Analytics. FDA recall D-0943-2023. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0943-2023. Source: US FDA. Licensed CC0.

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