D-762-2014 Class II Terminated
FDA drug recall D-762-2014 was initiated by Novartis Consumer Health on June 18, 2013 and is designated Class II. Reason for recall: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. The recall status is terminated (terminated November 4, 2014).
Recall Details
- Product Type
- Drugs
- Report Date
- January 29, 2014
- Initiation Date
- June 18, 2013
- Termination Date
- November 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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.
Reason for Recall
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Distribution Pattern
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Code Information
Lot #: a) 10119730, Exp 9/30/2013; b) 10115568, 10115570, Exp 6/30/2013; 10119728, Exp 9/30/2013.