Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118
Summary
The FDA issued a Class II for Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxyl by Denison Pharmaceuticals, LLC. Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel..
Details
Source
Drug Recall
External ID
D-0775-2023
Action Date
2023-06-07
Status
Ongoing
Category
drug
Product Description
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Lot/Code Info: Lot 8639, Exp: 8/2023
Quantity Affected: 13,968 bottles
Reason for Recall
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Distribution
Product was distributed Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-03
Company
Lincoln, RI
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 243 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Denison Pharmaceuticals, LLC has 8 FDA actions in our database, including 8 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 (Denison Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Denison Pharmaceuticals, LLC have FDA actions?
Denison Pharmaceuticals, LLC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0775-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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