FDAFDA · Food and drugs·Recall number D-738-2014
Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2082-32.
Published January 22, 2014 · Recall initiated: May 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Novartis Consumer Health
- Distributor
- Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
- Lot
- Lot # 10116279 exp 05/13 Lot # 10117810 exp 06/13 Lot # 10119274 exp 07/13 Lot # 10121463 exp 07/13
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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