FDA-Drug2023-06-07Class II
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.
Denison Pharmaceuticals, LLC
Hazard
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Sold states
Product was distributed Nationwide.
Affected count
13,968 bottles
Manufactured in
1 Powder Hill Rd, N/A, Lincoln, RI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0775-2023Don't want to check this manually?
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