Maximum Strength Comtrex recall: Impurity Out of Spec
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, NJ. 07054-0622, NDC 0067-2081-24
Why was Maximum Strength Comtrex recalled?
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# 10117247 06/13 Lot# 10119336 07/13
- 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, NJ. 07054-0622, NDC 0067-2081-24
- Recalling firm
- Novartis Consumer Health
- Quantity
- 167,712/24-caplet packages
- Distribution
- Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
- Recall date
- January 22, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)