J&J’s manufacturing recovery hits a hurdle
pharmafile | September 10, 2013 | News story | Manufacturing and Production | API, J&J, JJ, McNeil, Motrin, recall
Johnson & Johnson’s path back to regulatory compliance in its manufacturing operations has hit another snag after the firm was forced to recall 200,000 bottles of a Motrin product for infants.
The recall of three lots of concentrated Motrin (ibuprofen) infant drops in 1/2 flask-ounce bottles has been prompted by the risk of contamination with tiny plastic particles, according to a company statement.
Motrin is one of the flagship products in the portfolio of J&J’s McNeil Consumer Healthcare division, which has been at the centre of many of the manufacturing problems plaguing the company in recent years.
J&J said the 1mm to 2mm plastic shards – described as being “about the size of a poppy seed” – are thought to have originated from a shipment of bulk ibuprofen supplied by a third-party supplier, adding that McNeil “has worked with the third party to ensure that corrective measures are currently in place and are effective”.
The contamination was found in a shipment that was not released for marketing, but McNeil recalled all lots that used the API batch as a precautionary measure.
Much of the attention on J&J’s manufacturing issues focusses on McNeil’s Fort Washington facility in Philadelphia, which was shut down in 2010 and (FDA willing) is scheduled to re-open next year. The suspension has cost J&J an estimated $1 billion in lost sales plus $100 million-plus in upgrade and remediation spending.
Amid suspicion that the problems extended well beyond McNeil – quality failures have also impacted facilities in its medical device and prescription pharma business – J&J has undertaken a wide-ranging revamp of its manufacturing operations, appointing chief quality officers for example in each of its operating divisions.
Other measures have included the deployment of common quality standards, as well as an internal audit programme to ensure those standards are met both in-house and by its suppliers. The latest recall suggests that the company still has some way to go before it sets its house fully back in order.
Phil Taylor
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