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Letters were sent about eluxadoline (Truberzi), fingolimod (Gilenya), Bleo-Kyowa (bleomycin sulphate), Buccolam (midazolam), and ERWINASE.
Summary List of field safety notices (FSNs) from medical device manufacturers from 6 - 10 June 2016
Dr Reddy's Laboratories (UK) Ltd has informed us that the Patient Information Leaflet (PIL) for the specific batches listed in this alert are missing the special warning and precautions identified from post-marketing experience that are documented in the Summary of...
Sage Products Cooperatief UA: Precautionary recall of five batches due to low risk of microbiological contamination
There is a potential risk of fatal overdose due to confusion between lipid-based and non-lipid-based formulations of parenteral amphotericin B. These formulations are not interchangeable: prescribers, pharmacists, and nurses need to be fully aware of the formulation being used and...
B Braun Medical Ltd is recalling the above batch as a precautionary measure because the Company has received isolated reports of patient reactions (fever, shivering) associated with administration of the batch.
Enhanced stewardship approach for urinary tract infections (UTIs) resulted in a dramatic reduction in inappropriate prescribing.
(ViroPharma SPRL) Pharmacists should quarantine batches and return them to original wholesaler for credit - class 2 action within 48 hours. (EL (14)A/12)
New recommendations are being introduced to minimise the risk of serious hypersensitivity reactions with ferumoxytol.
Letters were sent on Typhim Vi vaccines, Mepact (mifamurtide), and Xeljanz (tofacitinib) and an alert issued to recall Emerade 150 microgram adrenaline pens.
Precautionary recall because a glass particle has been identified in one syringe from this batch.
Last month, letters were sent regarding ketoconazole HRA and radium-223 dichloride (Xofigo).
Summary List of field safety notices (FSNs) from medical device manufacturers from 30 May - 3 June 2016
Public Health England (PHE) to develop an innovative point of care test (POCT) to assess childhood immunity to measles and tetanus.
Letters were sent about Myocrisin (sodium aurothiomalate), Cerliponase alfa (Brineura▼), Darzalex▼(daratumumab), retinoids▼, and febuxostat (Adenuric). A recall alert was issued for medicines that were taken out of the regulated medicines supply chain during distribution. Other alerts were issued about paracetamol...
FDC International Ltd is recalling the batches listed below as a precautionary measure due to a precipitate observed in the bottles.
Letters were sent about Arsenic Trioxide (Trisenox), Uptravi▼ (selexipag), DepoCyte (cytarabine), Cinryze▼ (C1 esterase inhibitor [human]), and Clexane (enoxaparin sodium).
Specific batch distributed by Sandoz Ltd is being recalled due to particulate matter found in samples.
The EMA Veterinary Committee has concluded that the benefit:risk balance for veterinary medicines containing zinc oxide is negative and that this class of products should be withdrawn.
FDC International Ltd are recalling specific batches of Sodium Cromoglicate 2% w/v Eye Drops 13.5ml and Murine Hayfever Relief 2% w/v Eye Drops 10ml due to the presence of a precipitate, which has been identified as Sodium Cromoglicate, in some...
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