Novartis Recalls Comtrex Cold and Cough Caplets Due to Unknown Degradant
Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Day/Night Cold & Cough caplets 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 as a Class III recall, which indicates the product is not likely to cause adverse health consequences. The hazard is an unknown degradant found during stability testing, with no reported illnesses or injuries.
Plain-English summary
Novartis Consumer Health is voluntarily recalling 104,328 packages of Maximum Strength Comtrex Day/Night Cold & Cough. The product contains acetaminophen, chlorpheniramine maleate, dextromethorphan HBR, and phenylephrine HCL. The recall is being conducted because an unknown degradant was identified during stability testing.
The affected products are packaged in 32-caplet boxes containing 16 daytime and 16 nighttime coated caplets. The specific lots subject to recall are 10116279 (exp 05/13), 10117810 (exp 06/13), 10119274 (exp 07/13), and 10121463 (exp 07/13). The NDC number for the product is 0067-2082-32.
Distribution of the affected product was made nationwide as well as to 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 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: No
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Cold and Cough
- Hazard
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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