Multi-event June 2023 FDA Recall Drug by Kramer Laboratories, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Kramer Laboratories, Inc. on June 23, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0943-2023 TERMINATED D-0942-2023 TERMINATED

Recall Number: D-0943-2023

Reason for Recall
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Initiated
06-23-2023
Reported
08-02-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92407
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Kramer Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-12-2024
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : 8639, Exp. Date 8/2023

Recall Number: D-0942-2023

Reason for Recall
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Initiated
06-23-2023
Reported
08-02-2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92407
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Kramer Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-12-2024
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 8753, 8753A, Exp. Date 10/2023
Lot# : 8659 Exp. Date 8/2023