Letters and drug alerts sent to healthcare professionals in July 2020
A summary of letters and drug alerts recently sent to healthcare professionals, including recommendations to reduce handling errors with leuprorelin-containing depot medicines.
Leuprorelin-containing depot products
Leuprorelin-containing medicines are used to treat prostate cancer, breast cancer and conditions that affect the female reproductive system (endometriosis, uterine fibroids) and early puberty. Cases of handling errors, potentially resulting in lack of efficacy, have been reported with depot formulations.
Following a European review, the marketing authorisation holders of leuprorelin-containing depot products (Prostap, Staladex, Lutrate) have written to UK healthcare professionals to inform them that:
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handling errors have been reported with leuprorelin-containing depot medicinal products, potentially resulting in lack of efficacy
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the risk of handling errors is increased when there are multiple steps in the product reconstitution and administration process
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products should be prepared, reconstituted (if applicable), and administered only by healthcare professionals who are familiar with these procedures
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instructions for reconstitution and administration in the product information must be followed
See for more information.
Other letters
Wockhardt UK’s Amoxicillin Sodium 250mg, 500mg and 1g Powder for Solution for Injection. Healthcare professionals should also be aware of a letter issued 24 August 2020 to inform of caution and monitoring requirements when using Wockhardt UK’s Amoxicillin Sodium 250mg, 500mg and 1g Powder for Solution for Injection. This product can now be used with caution in neonates and infants, following the update of the previous MHRA advice not to use due reports of extravasation and injections site reactions. See updated drug alert for more information.
Drug Alerts from July 2020
Class 2 Medicines Recall: Mepacrine Hydrochloride 100 mg Tablets (Batch 85641), EL (20)A/27. Issued 2 July 2020. A specific batch of mepacrine 100mg tablets has been recalled due to a number of foreign body particulates found in the containers of the Active Pharmaceutical Ingredient (API) used in manufacturing. Patients who have been supplied with the affected batch should be contacted and asked to stop using these tablets and to return any unused medicine to their pharmacy.
Class 2 Medicines Recall: Nitrofurantoin 50 mg Tablets, PL 08553/0087, EL (20)A/28. Issued 15 July 2020. A specific batch of nitrofurantoin 50mg tablets has been recalled from pharmacies and wholesalers as a precautionary measure due to out of specification results for dissolution during routine stability testing.
Class 2 Medicines Recall: Ferring Pharmaceuticals Limited, desmopressin nasal spray (all strengths), PL 03194/0024, PL 03194/0090, PL 03194/0056, EL (20)A/29. Issued 15 July 2020. All unexpired stock of the products listed has been recalled from pharmacies and wholesalers as a precautionary measure due to a lower volume of solution being observed in the bottles, and out-of-specification results for the content of the desmopressin acetate (active substance) and benzalkonium chloride (excipient).
Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/34. Issued 29 July 2020. A specific batch has been recalled as a precautionary measure due to the reports of double tablets in a single blister pocket.
Class 3 Medicines Recall: Accord Healthcare Limited, Irinotecan Hydrochloride Concentrate for Solution for Infusion 20mg/ml (5ml vial), EL (20)A/33. Issued 23 July 2020. A specific batch has been recalled as a precautionary measure due to the observation of precipitation in the solution in the same batch marketed in another country (Malta).
Class 4 Medicines Defect Information: Pfizer Limited, Ecalta 100mg powder for concentrate for solution for infusion, EL (20)A/32. Issued 23 July 2020. Pfizer Limited has informed us that the packs for the affected batches below have not been packaged with the current version of the Patient Information Leaflet (PIL) containing updated storage instructions. The infusion solution must not be frozen.
Class 4 Medicines Defect Information: Ennogen Pharma Limited, Trimogal 100mg and 200mg Tablets, EL (20)A/31. Issued 20 July 2020. The Patient Information Leaflets within the packs for the affected batches contain an error with regard to the dosage instruction for children younger than 6 years. The correct PIL is available from the electronic medicines compendium (EMC) website and the MHRA website, and should be used when dispensing packs from the affected batches.
Class 4 Medicines Defect Information: Aspar Pharmaceuticals Limited, Ibuprofen 200mg and 400mg tablets packaged in various liveries, EL (20)A/30. Issued 20 July 2020. The Patient Information Leaflets (PILs) within the ibuprofen packs listed are missing some information identified from post-marketing experience that should be documented in Section 3 (How To Take The Tablets) and Section 4 (Possible Side Effects) of the PIL. Please ensure that patients are aware of the missing information and know to seek immediate medical advice in the situations described in the updates.
Article citation: Drug Safety Update volume 14, issue 1: August 2020: 7.