NeoCitran Extra Strength Non-Drowsy Cold & Sinus — Class II drug recall D-761-2014
Terminated recall by Novartis Consumer Health, reported 2014-01-29, distributed nationwide. Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
| Recall number | D-761-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Consumer Health, Lincoln, NE, United States |
| Recall initiated | 2013-06-18 |
| Classified | 2014-01-17 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, KR, MX, PA, RU |
| UPC / GTIN / UDI-DI | 00058478057033 |
| NDC | 00067-7116-06 |
| Lot numbers | 10116030 |
| Expiration dates | 2013-05-31, 2013-06-30, 2013-07-31 |
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 for recall
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-761-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.