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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- 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.
See all 7 products in this recall →Related recalls
Same manufacturer · Novartis Consumer Health
See all →- ModerateNovartis Recalls Benefiber Fiber Supplement Stick Packs Due to Consumer Complaints
FDA (Food) · 2014-03-05
- ModerateNovartis Recalls Theraflu Severe Cold & Cough Powder Packets for Foreign Substances
FDA (Drugs) · 2014-01-29
- HighNovartis Recalls Theraflu Powder Packets Due to Foreign Substance Presence
FDA (Drugs) · 2014-01-29
- ModerateNovartis Recalls NeoCitran Extra Strength Powder Packets Due to Foreign Substances
FDA (Drugs) · 2014-01-29
- ModerateNovartis Recalls Theraflu Exte Powder Packets Due to Foreign Substances
FDA (Drugs) · 2014-01-29
Same hazard · unknown degradant
See all →- ModerateNovartis Recalls Excedrin Sinus Headache Caplets Due to Unknown Degradant
FDA (Drugs) · 2014-01-22
- LowNovartis Recalls Comtrex Nighttime Cold and Cough Due to Unknown Degradant
FDA (Drugs) · 2014-01-22
- LowNovartis Recalls Theraflu Nighttime Warming Relief Due to Unknown Degradant
FDA (Drugs) · 2014-01-22
- LowNovartis Recalls Comtrex Cold and Cough Caplets Due to Unknown Degradant
FDA (Drugs) · 2014-01-22
- LowNovartis Recalls Theraflu Warming Relief Due to Unknown Degradant
FDA (Drugs) · 2014-01-22
Similar recalls
- ModerateNovartis Recalls NeoCitran Extra Strength Powder Packets Due to Foreign Substances
FDA (Drugs) · 2014-01-29
- ModerateNovartis Recalls NeoCitran Cold and Flu Powder Packets Due to Foreign Substances
FDA (Drugs) · 2014-01-29
- LowNovartis Recalls No Doz Max Strength Caffeine Caplets Due to Packaging Defect
FDA (Drugs) · 2013-08-14
- ModerateNovartis Recalls Theraflu Cold and Cough Powder Packets
FDA (Drugs) · 2014-01-29
- ModerateNovartis Recalls Theraflu MAX-D Powder Packets Due to Foreign Substances
FDA (Drugs) · 2014-01-29
- HighTheraflu Nighttime Severe Cold & Cough Powder Packets Recalled for Foreign Substances
FDA (Drugs) · 2014-01-29