FDA Drug recall D-743-2014
Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 1…
- FDA Drug
- Class III
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class III recall of Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 1… by Novartis Consumer Health, citing failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-743-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-05-15 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Novartis Consumer Health |
| Distribution | US |
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 Consumer Health, Inc., Parsippany, NJ. 07054-0622.
Reason
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Identifiers
| code_info | a) 08 caplets: Lot# 10121222 exp 07/13. b) 24 caplets: Lot# 10117231 exp 06/13 Lot# 10117814 exp 06/13…a) 08 caplets: Lot# 10121222 exp 07/13. b) 24 caplets: Lot# 10117231 exp 06/13 Lot# 10117814 exp 06/13 Lot# 10119341 exp 07/13 Lot# 10123425 exp 08/13 Lot# 10124156 exp 10/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-743-2014%22
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