Letters and drug alerts sent to healthcare professionals in November 2019

Letters were sent about ranibizumab and Emerade adrenaline auto-injectors. Alerts were issued about ranitidine, paracetamol, omeprazole, mitomycin-C Kyowa, folic acid, and Emerade adrenaline auto-injectors.

Letters sent in November 2019

Ranitidine – further recall

Previously we highlighted recalls for ranitidine medicines due to possible contamination with an impurity N-nitrosodimethylamine (NDMA), which has genotoxic and carcinogenic potential. Since publication of this article on 21 November 2019, a further recall alert has been issued: Class 2 Medicines recall: Ranitidine 150mg Film-Coated Tablets, PL 20075/0063, Ranitidine 300mg Film-Coated Tablets, PL 20075/0064 (EL(19)A/40). Issued 5 December 2019. Accord Healthcare are recalling all unexpired stock from pharmacies and retail stores. For the latest recalls, see Alerts and recalls for drugs and medical devices.

Other recall alerts

Class 2 Medicines Recall: Emerade 150, 300 and 500 microgram solution for injection in a pre-filled syringe (MDR 57-08/19). Issued 28 November 2019. Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerede Adrenaline Autoinjectors after identifying an error than can cause some pens to fail to activate.

Class 2 Medicines Recall: M&A Pharmachem Limited Paracetamol 500 mg Tablets, 1 x 1000, PL 04077/0001, (EL(19)A/38. Issued 27 November 2019. M&A Pharmachem Limited is recalling all unexpired batches as a precautionary measure because a small number of pots from some batches were found to contain discoloured tablets due to contamination with fungus (Penicillium citrinum). This is an update to alert EL(19)A/32, issued 5 November 2019.

Class 2 Medicines Recall: Sandoz Limited, Omeprazole 40 mg Powder for Solution for Infusion, PL 04416/0701 (EL(19)A/34). Issued 11 November 2019. Sandoz Limited is recalling one batch (JS1355) due to the occurrence of degradation in some vials, resulting in green discoloration of the powder in the vial, leading to increased levels of impurities/degradation products in the medicine.

Class 2 Medicines Recall: Kyowa Kirin Limited Mitomycin-C Kyowa, All Strengths (see alert for more information), (EL (19)A/33). Issued 7 November 2019. All unexpired batches of Kyowa Kirin Mitomycin-C Kyowa products are being recalled as a precautionary measure due to deviations from the aseptic manufacturing processes during the manufacture of the sterile active pharmaceutical ingredient and excipients.

Class 3 Medicines Recall: Folic Acid Tablets BP 5mg, PL 0142/5522, (EL(19)A/35). Issued 18 November 2019. Accord-UK has advised of an issue related to decommissioning of the batch HU57. Although there is no risk to product quality, any remaining stock should be quarantined and returned.

Article citation: Drug Safety Update volume 13, issue 5: December 2019: 2.

Published 16 December 2019