Why it was recalled
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
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).
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-757-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 18, 2013
- FDA report date
- Jan 29, 2014
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Consumer Health
Original FDA data
Every field from FDA enforcement report D-757-2014, exactly as published.
Show all FDA fields
- City
- Lincoln
- State
- NE
- Status
- Terminated
- Country
- United States
- Event ID
- 65490
- Address
- 10401 Hwy 6
- Code information
- 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.
- Postal code
- 68517-9626
- Report date
- Jan 29, 2014
- Product type
- Drugs
- Recall number
- D-757-2014
- Classification
- Class II
- Recalling firm
- Novartis Consumer Health
- Termination date
- Nov 4, 2014
- Reason for recall
- Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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).
- Distribution pattern
- Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
- Recall initiation date
- Jun 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 17, 2014