Letters and drug alerts sent to healthcare professionals in April 2019
Letters were sent about alemtuzumab (Lemtrada), Selenase (sodium selenite pentahydrate), and Erelzi▼ (etanercept).
Letters
In April 2019, the following letters were sent to healthcare professionals:
Drug alerts
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Class 4 Medicines Defect Information: Zoledronic acid 5mg solution for infusion (MDR 51-03/19). Issued 4 April 2019. Some packs from the listed batch contain the wrong Patient Information Leaflet. When dispensing, please check the Patient Information Leaflet and replace if needed.
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Company led drug alert - Nutriflex Omega Special 2500ml. Issued 8 April 2019. Batches are being recalled as ongoing stability studies have identified that they may have an out-of-specification result in the glucose chamber at the end of shelf-life.
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Class 4 Medicines Defect Information: Chloramphenicol 0.5% W/V Antibiotic Eye Drops (MDR 105-03/19). Issued 9 April 2019. Braille is missing from the carton and the packs contain the Patient Information Leaflet (PIL) for the product with legal status ‘POM’.
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Class 4 Medicines Defect Information: Ativan 4mg/1ml Solution for injection (MDR 57-04/19). Issued 24 April 2019. The product description on the carton was changed from 10 x 1 ml ampoules to 10 x 2 ml ampoules. The updated text reflects the size of the ampoules, which is 2 ml. The concentration and total volume of the ampoules has not changed and remains 4 mg lorazepam in 1 ml of solution.
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Class 4 Medicines Defect Information: Prednisolone 5mg Tablets (MDR 61-04/19). Issued 26 April 2019. An error on the braille means that the strength reads as 1 mg instead of 5 mg.
For the latest alerts, including those from May 2019 on Macopharma intravenous infusion bags and Co-amoxiclav Power for Oral Suspension, see Alerts and recalls for drugs and medical devices.
Article citation: Drug Safety Update volume 12, issue 10: May 2019: 5.