CLASS III Drug recall · Reported 22 Jan 2014 · FDA Enforcement Report
Maximum Strength Comtrex , Day/Night Flu Therapy recalled
Novartis Consumer Health is recalling Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine, distributed nationwide in the US. The recall was initiated on 15 May 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-740-2014
- FDA event ID
- 65181
- Recalling firm
- Novartis Consumer Health, Lincoln, NE
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 May 2013
- FDA classified
- 16 Jan 2014
- Reported
- 22 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 15 May 2013 | Recall initiated by company | |
| 16 Jan 2014 | Classified by FDA | +246 days |
| 22 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2084-24.
Where it was distributed
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Which lots are affected?
Lot# 10117243 Exp 06/13 Lot# 10119333 Exp 07/13
Where was it sold?
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 65181This product is part of a recall event; the main page for the event is Theraflu Nighttime Warming Relief Nighttime Multi-Symptom recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Theraflu Nighttime Warming Relief Nighttime Multi-Symptom recalled | Novartis Consumer Health | Potency & Assay | Nationwide | |
| CLASS III | Maximum Strength Comtrex Day/Night Cold & Cough recalled | Novartis Consumer Health | Potency & Assay | Nationwide | |
| CLASS III | Excedrin, Sinus Headache, Acetaminophen 325mg recalled | Novartis Consumer Health | Potency & Assay | Nationwide | |
| CLASS III | Theraflu Warming Relief, Multi-Symptom Cold recalled | Novartis Consumer Health | Potency & Assay | Nationwide | |
| CLASS III | Maximum Strength Comtrex Nighttime Cold & Cough recalled | Novartis Consumer Health | Potency & Assay | Nationwide | |
| CLASS III | Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen recalled | Novartis Consumer Health | Potency & Assay | Nationwide |
More recalls from Novartis Consumer Health
All 60| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | Benefiber fiber supplement stick packs, sugar free and taste free recalledBenefiber | Novartis Consumer Health | Packaging Defects | Nationwide |
| Drug | CLASS II | Theraflu Flu & Sore Throat (acetaminophen 650 mg recalled | Novartis Consumer Health | Packaging Defects | Nationwide |
| Drug | CLASS II | Theraflu Exte (dextromethorphan hydrobromide 20 mg recalled | Novartis Consumer Health | Packaging Defects | Nationwide |
| Drug | CLASS II | Theraflu Nighttime Severe Cold & Cough recalled | Novartis Consumer Health | Packaging Defects | Nationwide |
| Drug | CLASS II | Theraflu Flu & Chest Congestion (acetaminophen 1000 mg recalled | Novartis Consumer Health | Other | Nationwide |
Other Maximum Strength Comtrex recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen recalled | Novartis Consumer Health | Potency & Assay | Nationwide |