Drug product
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.
D-762-2014
Product summary
- Event
- Event 65490
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-762-2014
Official wording
Reason: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Code information: Lot #: a) 10119730, Exp 9/30/2013; b) 10115568, 10115570, Exp 6/30/2013; 10119728, Exp 9/30/2013.
Distribution pattern: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance