FDA Drug recall D-761-2014
NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Sourc…
- FDA Drug
- Class II
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class II recall of NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Sourc… 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-761-2014 |
| 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
NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05703 3. Also packaged under foreign label: Theraflu Daytime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7116-06, UPC 8 806536 01402 1 (Korea Product)
Reason
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Identifiers
| upc | 058478057033 |
|---|---|
| upc | 8806536014021 |
| code_info | Lot #: 10116030, Exp 6/30/2013. Korea product: 10112972, Exp 5/31/2013 and 10116032, Exp 7/31/2013. |
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-761-2014%22
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