Why it was recalled
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Product description
Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distributed by Novartis Farmaceutica, S.A., DE C.V., Mexico.
Lot numbers, UPCs & expiration codes
Lot #: a) 10119730, Exp 9/30/2013; b) 10115568, 10115570, Exp 6/30/2013; 10119728, Exp 9/30/2013.
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-762-2014
- 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-762-2014, 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) 10119730, Exp 9/30/2013; b) 10115568, 10115570, Exp 6/30/2013; 10119728, Exp 9/30/2013.
- Postal code
- 68517-9626
- Report date
- Jan 29, 2014
- Product type
- Drugs
- Recall number
- D-762-2014
- 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
- Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distributed by Novartis Farmaceutica, S.A., DE C.V., Mexico.
- 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