Status
Terminated
Drug Enforcement D-757-2014
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Classification
Class II
Report Date
January 29, 2014
Termination Date
November 4, 2014
Product Information
- Product description
- NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine maleate 4 mg, ascorbic acid 5 mg) powder packets, Soothing Lemon flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, labeled as a) NeoCitran Extra Strength Nighttime Total 7 Symptom Relief (UPC 0 58478 10063 0) and b) NeoCitran Extra Strength Cough, Cold & Flu (UPC 0 58478 47363 5).
- Product quantity
- —
- Reason for recall
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Location & Firm
- Recalling firm
- Novartis Consumer Health
- Address
-
10401 Hwy 6
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-757-2014
- Event ID
- 65490
- Recall initiation date
- June 18, 2013
- Center classification date
- January 17, 2014
- Code info
- Lot #: a) 10094895, Exp 7/31/2013; 10098586, Exp 9/30/2013; 10104820, Exp 12/31/2013; 10109982, Exp 2/28/2014; 10110876, Exp 3/31/2014; 10114393, Exp 5/31/2014; 10119851, Exp 7/31/2014; 10122313, Exp 9/30/2014; b) 10097661, Exp 8/31/2013; 10099912, Exp 9/30/2013; 10105539, Exp 12/31/2013; 10109980, Exp 2/28/2014; 10114396, Exp 5/31/2014; 10119849, Exp 7/31/2014; 10122312, Exp 9/30/2014.
- More code info
- —