Maximum Strength Comtrex Nighttime Cold & Cough recall: Impurity Out of Spec
Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24.
Why was Maximum Strength Comtrex Nighttime Cold & Cough recalled?
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 10119267 exp 07/13 Lot # 10123857 exp 07/13 Lot # 10123888 exp 09/13
- Product
- Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24.
- Recalling firm
- Novartis Consumer Health
- Quantity
- 32,256/24-caplet packages
- Distribution
- Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
- Recall date
- January 22, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)