Bridgewater, NJ, United States
Kramer Laboratories, Inc. recalls
1 recall recorded since 2018, most recently on 23 June 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 23 June 2023
- Terminated
- 12 March 2024
- Reason
- CGMP Deviations: use of non-food grade lubricant in mixing vessel.
- Distribution
- nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0942-2023, D-0943-2023
- Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807
- Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.