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.
Reported: January 22, 2014 Initiated: May 15, 2013 #D-738-2014
Product Description
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.
Reason for Recall
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Details
- Recalling Firm
- Novartis Consumer Health
- Units Affected
- 104,328/32-caplet packages
- Distribution
- Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
- Location
- Lincoln, NE
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Novartis Consumer Health. Units affected: 104,328/32-caplet packages.
Why was this product recalled? ▼
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 22, 2014. Severity: Low. Recall number: D-738-2014.
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