Novartis Recalls Theraflu Nighttime Warming Relief Due to Unknown Degradant
Novartis Consumer Health is recalling Theraflu Nighttime Warming Relief 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 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 specific lots of Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold caplets. The recall involves 8-caplet and 24-caplet packages containing acetaminophen, chlorpheniramine maleate, dextromethorphan HBr, and phenylephrine HCl. The affected products were distributed nationwide and in Mexico, Panama, Ecuador, and Venezuela.
The recall was initiated because an unknown degradant was identified during stability testing. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who have the affected products should stop using them and return them to the place of purchase for a refund. The specific lot numbers and expiration dates for the recalled products are listed in the official recall notice.
The recalled product
- Product
- Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24). Distributed by: Novartis Consume
- Manufacturer
- Novartis Consumer Health
- 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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