Novartis Recalls Maximum Strength Comtrex Due to Unknown Degradant
Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Severe Cold & Sinus 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 recall is classified as FDA 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 167,712 packages of Maximum Strength Comtrex Severe Cold & Sinus. The product contains acetaminophen, chlorpheniramine maleate, and phenylephrine HCL and is packaged in 24-caplet boxes containing daytime and nighttime formulas. The recall involves Lot # 10117247 (expiration 06/13) and Lot # 10119336 (expiration 07/13).
The recall was initiated because an unknown degradant was identified during stability testing. This is classified as an FDA Class III recall, which indicates that the 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 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 instructions on disposal or return.
The recalled product
- Product
- Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, N
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Cold & Sinus
- 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# 10117247 06/13 Lot# 10119336 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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