FDAnews Drug Daily Bulletin

Novartis Recalls Batches of Children’s Cough Medicine in UK

Dec. 18, 2013

Novartis’s UK branch is recalling certain batches of its Tixylix, a brand of children’s cough medicine, over a manufacturing flaw in the tamper seal that might leave traces of plastic in the medicine itself.

The recall, which affects batches of five drug products for toddlers and babies, four glycerol-based and one guaifenesin-based, manufactured after October 2012, is being conducted in cooperation with the UK’s Medicines and Healthcare products Regulatory Agency.

Novartis says no adverse events have been reported as a result of the tamper seal flaw and asks customers to contact the company to return the product. Pharmacists and drugstores should quarantine existing product and return it to suppliers, the company says.

Read Novartis UK’s recall notice at www.fdanews.com/ext/resources/files/12/12-18-13-NovartisRecall2.pdf. For a full list of affected batches, view www.fdanews.com/ext/resources/files/12/12-18-13-NovartisRecall.pdf. — Lena Freund

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