Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4
Summary
The FDA issued a Class II for Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant by Kramer Laboratories, Inc.. Reason: CGMP Deviations: use of non-food grade lubricant in mixing vessel..
Details
Source
Drug Recall
External ID
D-0942-2023
Action Date
2023-08-02
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: 8753, 8753A, Exp. Date 10/2023 Lot #: 8659 Exp. Date 8/2023
Quantity Affected: N/A
Reason for Recall
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Distribution
nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-23
Company
Bridgewater, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 51 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Kramer Laboratories, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Kramer Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Kramer Laboratories, Inc. have FDA actions?
Kramer Laboratories, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0942-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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