FDA Drug recall D-748-2014
Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural App…
- FDA Drug
- Class II
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class II recall of Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural App… 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-748-2014 |
| 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 Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7916-06, UPC 3 0043-0479-16 3. Also packaged under foreign label: NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Apple Cinnamon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05205 2.
Reason
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Identifiers
| upc | 300430479163 |
|---|---|
| upc | 058478052052 |
| code_info | Lot #: 10115121, 10115832, Exp 5/31/2013; 10119854, 10119856, Exp 7/31/2013; 10122257, 8/31/2013; 10124286, 10124289, 1…Lot #: 10115121, 10115832, Exp 5/31/2013; 10119854, 10119856, Exp 7/31/2013; 10122257, 8/31/2013; 10124286, 10124289, 10124292, Exp 9/30/2013; 10128103, 10128105, 10128108, 10128110, Exp 10/31/2013. NeoCitran Cold & Flu: 10115118, Exp 5/31/2013 and 10122252, 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-748-2014%22
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