Novartis Recalls Maximum Strength Comtrex Day/Night Flu Therapy
Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Day/Night Flu Therapy due to an unknown degradant 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 recall is classified as FDA Class III, 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 injuries or illnesses.
Plain-English summary
Novartis Consumer Health is voluntarily recalling specific lots of Maximum Strength Comtrex Day/Night Flu Therapy. The product is a combination medication containing acetaminophen, chlorpheniramine maleate, dextromethorphan HBr, and phenylephrine HCL, packaged in 24-caplet boxes with 12 daytime and 12 nighttime formula caplets.
The recall was initiated because an unknown degradant was identified during stability testing. The affected products are identified by Lot # 10117243 (Expiration 06/13) and Lot # 10119333 (Expiration 07/13). The NDC number for the product is 0067-2084-24.
Distribution of the affected product was made nationwide and to foreign markets, including Mexico, Panama, Ecuador, and Venezuela. Consumers should check their medication for the specific 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 Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health
- 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# 10117243 Exp 06/13 Lot# 10119333 Exp 07/13
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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