Letters and drug alerts sent to healthcare professionals in October 2019

Letters were sent about quadrivalent influenza vaccine, fentanyl ampoules, and Volibris (ambrisentan), and a number of pharmacy-level recalls were issued for ranitidine-containing products. Other alerts issued in October 2019 are also summarised in this article.


Ranitidine: pharmacy-level recalls

There has been a number of pharmacy-level recalls for ranitidine-containing products as a precautionary measure due to possible contamination with N-nitrosodimethylamine (NDMA), an impurity thathas genotoxic and carcinogenic potential. This impurity was also detected in sartan medicines, leading to their recall earlier this year.

This is an ongoing issue and the MHRA is actively involved with the European Medicines Agency and with other medicines regulators. An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses.

At the time of publication, class 2 recalls have been issued for the following products:

Pharmacies are advised to stop supplying affected products immediately and to return them to their supplier. If patients are concerned, advise them to contact their GP, pharmacist, or healthcare professional to review ongoing treatment.

The Department of Health and Social Care issued a Supply Distribution Alert (SDA/2019/005) for all oral formulations of ranitidine on 15 October 2019.

Other recalls

Class 2 medicines recall: Sayana Press 104mg/0.65ml (MDR 055-06/19). Issued 23 October 2019. Pfizer is recalling certain batches of Sayana Press (medroxyprogesterone acetate) suspension for subcutaneous injection. This is because of an issue related to the sealing process that may impact the integrity of the product. Affected batches should be returned to the supplier.

Class 2 medicines recall: Nutriflex Omega Plus 1250ml, 1875ml and 2500ml, and Nutriflex Omega Special 625ml, 1250ml, 1875ml and 2500ml, and Supplemented Product codes ASNSPOMCA, ASNSPOMSVA, ASNPLOMCA, ASNPLOMSVA (625ml, 1250ml, 1875ml 2500ml) (EL(19)A/31). Issued 30 October 2019. B Braun is initiating a recall of certain batches of the above products as a precautionary measure. This is because ongoing product monitoring has identified that some bags may not comply with the required specification throughout the product shelf-life.

Company-led drug alert: Avonex 30 micrograms/0.5ml Solution for Injection. Issued 23 October 2019. Biogen Idec UK is recalling batches of Avonex at wholesaler, pharmacy, and homecare provider level due to a manufacturing issue. The issue could potentially have resulted in a loss of sterility assurance and may have weakened the glass structure of the syringe with the possible formation of particulate matter.

Company-led drug alert: Docetaxel Injection 80mg /8ml. Issued 22 October 2019. Pfizer UK is recalling batches as routine stability testing has identified that levels of a known impurity, 10-oxo-docetaxel, may exceed the acceptable level at end of shelf-life.

Defect information

Class 4 Medicines Defect Information: Xonvea 10 mg/10 mg gastro-resistant tablets (MDR 025-10/19). Issued 16 October 2019. Some side effects documented in the Summary of Product Characteristics for Xonvea (manufactured by Alliance Pharmaceuticals) are not included in the Patient Information Leaflet provided with listed batches. These include antihistamine anticholinergic effects and rarely, effects on white blood cell production. If dispensing a listed batch, healthcare professionals are asked to ensure patients are aware of the missing information. Newly released batches on the market will include the updated patient leaflet.

Class 4 Medicines Defect Information: Rifadin (rifampicin) 150mg Capsules (MDR 127-09/19). Issued 16 October 2019. The Patient Information Leaflet for the listed batch of Rifadin 150mg capsules does not several important side effects. If dispensing from the listed batch, please remove the leaflet and replace with the updated version.

In October a Class 4 Medicines Defect Information alert was also issued for Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 57-08/19). See Drug Safety Update October 2019 for more information.

Article citation: Drug Safety Update volume 13, issue 4: November 2019: 3.

Published 21 November 2019