Recalling firm
Kramer Laboratories, Inc.
Product type
Drug
Status
Terminated
Report date
2023-08-02
Distribution
nationwide within the United States
Firm state
NJ
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Product description
Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
Code / lot info
Lot #: 8639, Exp. Date 8/2023
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.