FDA Drug recall D-742-2014
Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated…
- FDA Drug
- Class III
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class III recall of Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated… 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-742-2014 |
| 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 Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) 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# 10121228 exp 08/13. b) 24caplets: Lot# 10114814 exp 05/13 Lot# 10117233 exp 05/13 Lo…a) 08 caplets: Lot# 10121228 exp 08/13. b) 24caplets: Lot# 10114814 exp 05/13 Lot# 10117233 exp 05/13 Lot# 10117811 exp 06/13 Lot# 10119338 exp 07/13 Lot# 10121470 exp 07/13 Lot# 10123892 exp 09/13 Lot# 10124161 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-742-2014%22
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