TABLE I

Examples of Quality Defects and Recalls in 2018a

March 2018Product mix-up issue at a compounding siteNitrofurantoin (an antibiotic for bladder infections) was mistakenly used when manufacturing a nadolol (beta-blocker) oral solution for a patient. The batch in question was discarded prior to use.
April 2018Various packaging and labeling issuesWrong expiry dates assigned to nine batches of a product. Recall required in Ireland. Wrong package leaflet supplied with a bisphosphonate product. Recall required in Ireland.
June 2018Probable carcinogenic impurity in batches of valsartan APIGlobal recall. (22 different products across 6 companies recalled in Ireland.)
August 2018Use of the wrong excipient resulting in benzyl alcohol contamination of the productCompany's risk assessment for the issue not accepted by the HPRA.Several batches recalled in Ireland.
September 2018Risk of silicone particles in a steroid eye implant productGlobal recall, over 80 batches recalled to user level in various countries.

  • ↵a Reference 6.