Maximum Strength Comtrex Day/Night Cold & Cough — Class III drug recall D-738-2014
Terminated recall by Novartis Consumer Health, reported 2014-01-22, distributed nationwide. Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
| Recall number | D-738-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Consumer Health, Lincoln, NE, United States |
| Recall initiated | 2013-05-15 |
| Classified | 2014-01-16 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2014-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | EC, PA, VE |
| Reason classes | specification failure |
| NDC | 00067-2082-32 |
| Lot numbers | 05/13, 06/13, 07/13, 10116279, 10117810, 10119274, 10121463 |
Product
Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2082-32.
Reason for recall
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-738-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.