FDA Drug recall D-756-2014
Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powde…
- FDA Drug
- Class II
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class II recall of Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powde… by Novartis Consumer Health, citing presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-756-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-18 |
| Published | 2014-01-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Novartis Consumer Health |
| Distribution | US |
Product
Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6256-06, UPC 3 0043-6256-06. Also packaged under foreign label: NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, diphenhydramine hydrochloride 25 mg, Soothing Honey Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., UPC 0 58478 10594 9.
Reason
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Identifiers
| upc | 30043625606 |
|---|---|
| upc | 058478105949 |
| code_info | Lot #: 1011525, 10115834, Exp 5/31/2013; 10116012, 10116043, 10116045, 10116047, 10116049, 10117462, 10118936 Exp 6/30/…Lot #: 1011525, 10115834, Exp 5/31/2013; 10116012, 10116043, 10116045, 10116047, 10116049, 10117462, 10118936 Exp 6/30/2013; 10118683, 10118685, 10118934, 10118938, Exp 7/31/2013; 10122278, 10122280, 1012282, Exp 8/31/2013; 10124331, 10124333, 10124335, 10125908, Exp 9/30/2013; 10125923, 10126909, 10126911, 10127023, 10127026, Exp 10/31/2013. NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief: 10116036, Exp 6/30/2013 and 10122273, Exp 9/30/2013. |
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-756-2014%22
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