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Novartis UK pulls kids' cough syrup after CMO reports packaging defect

By Dan Stanton+

16-Dec-2013

Novartis has recalled 37 batches of over-the-counter (OTC) cough syrup after its contract manufacturer, BCM, detected a fault on a packaging line at its UK plant.

Last week, UK pharmacy chain Boots recalled some of its own-brand drugs made by its in-house contract manufacturing organization (CMO) BCM at a facility in Nottingham, because of a potential defect with the packaging's tamper seal that could result in small pieces of plastic being found in the bottles.

The CMO also makes the Tixylix paediatric liquid cough and cold medicines range on behalf of Novartis Consumer Health (NCH) and therefore specific batches have also been recalled by the firm, Julie Morrow, a Novartis UK spokesperson, told this publication.

“Whilst the presence of pieces of plastic in Tixylix medicines is not confirmed, and the potential occurrence of this defect is very low, as a precaution, NCH is recalling the batches from consumers, retail customers and wholesalers in the UK.”

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced the voluntary recall, Friday, for certain batches of Tixylix baby and toddler syrup manufactured from October 2012, though Adam Burgess - Head of Defective Medicines Reporting Centre - echoed Morrow’s words, saying this was “a precautionary recall and there is currently no evidence that people have had any problems with these medicines.”

BCM

Last week, Boots told in-Pharmatechnologist.com the recall of its own products was due to the detection of the tamper evident ring on the product packaging being pushed up during the manufacturing process.

“This may have caused it to become loose and break, creating a small risk, creating a small risk that pieces of plastic could fall into the medicine,” we were told, though corrective actions to the manufacturing line have begun including the addition of a camera-based visual detection system.

No other Novartis products have been affected, and neither Morrow nor Boots was able to comment on products from any other companies.

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