Novartis Recalls Comtrex Nighttime Cold and Cough Due to Unknown Degradant
Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Nighttime Cold & Cough because an unknown degradant was found during stability testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Novartis Consumer Health is recalling 32,256 packages of Maximum Strength Comtrex Nighttime Cold & Cough. The affected product is the 24-coated caplet nighttime formula containing acetaminophen, chlorpheniramine maleate, dextromethorphan HBR, and phenylephrine HCL. The recall covers three specific lots: 10119267 (exp 07/13), 10123857 (exp 07/13), and 10123888 (exp 09/13).
The recall was initiated because an unknown degradant was identified during stability testing. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected products were distributed nationwide and in Mexico, Panama, Ecuador, and Venezuela. Consumers should check their medication for the lot numbers and expiration dates listed above. If the product matches the recalled lots, consumers should stop using it and contact their pharmacist or Novartis Consumer Health for further instructions.
The recalled product
- 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., Parsipp
- Manufacturer
- Novartis Consumer Health
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 10119267 exp 07/13 Lot # 10123857 exp 07/13 Lot # 10123888 exp 09/13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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