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B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification.
Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Clarithromycin 250mg and 500mg film-coated tablets.
Brown & Burk UK Limited have noticed an error regarding specific batches of Amoxicillin 500 mg/ 5 ml Powder for oral suspension. The product information incorrectly states the quantity of the excipient sodium benzoate.
Based on MHRA’s review of available data, the Commission on Human Medicines’ Paediatric Medicine Expert Advisory Group (PMEAG) has advised that Wockhardt UK’s Amoxicillin Sodium Powder for Solution for Injection can be used with caution in neonates and infants.
Antibiotice SA have identified an error on PIL of the above batches regarding the sodium content.
(Wockhardt UK Ltd) Remaining stock from affected batches should be quarantined and returned to the original supplier for credit - class 2 action within 48 hours. (EL (14)A/11)
(Wockhardt UK Ltd) Should not be used in neonates and infants under 1 year old until further notice. (EL (14)A/09)
Sandoz limited has informed the MHRA that the products mentioned in this notification are not sugar free despite the carton stating ‘sugar free’. The ‘sugar free’ text was added to the carton in December 2008 in error.
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
Brancaster Pharma Limited have notified us of an issue relating to the label of the Water for Injections (solvent) packaged in each finished product pack.
Fresenius Kabi Ltd is recalling the above batch of Sodium chloride 0.9% Solution for injection (PL 08828/0178) which has a polish labelled ampoule within some of the cartons. As this does not impact the full batch, as a precautionary measure...
(GlaxoSmithKline) Check each vial for cracks by turning upside down and looking for chips, cracks or damage where base meets side wall. (EL (14)A/15)
Orion Corporation T/A Orion Pharma (UK) Ltd are recalling specific batches as a precautionary measure due to an issue related to moulding defects in the bulk chambers where the inhalation powder is stored.
Accord Healthcare Limited has informed us that that a change to the Patient Information Leaflet (PIL) for this product has not been implemented by the required timeline.
A summary of letters and drug alerts recently sent to healthcare professionals.
Sandoz Ltd. have been notified of a potential packaging problem relating to poor seal adherence which could cause clumping of the powder within the bottle.
Medreich has provided handling instructions following several complaints that the child-resistant caps are difficult to open (EL(16)A/17)
Caution in Use: Distribute to Hospital Pharmacy and Ward Level.
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