Drug 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)
D-761-2014
Product summary
- Event
- Event 65490
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-761-2014
Official wording
Reason: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Code information: Lot #: 10116030, Exp 6/30/2013. Korea product: 10112972, Exp 5/31/2013 and 10116032, Exp 7/31/2013.
Distribution pattern: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance