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Class 4 Medicines Defect Information: Altan Pharma Limited, Phenylephrine 0.08 mg/ml – solution for injection/infusion, EL(22)A/29
Altan Pharma Limited have identified an error relating to the product packaging. The incorrect concentration of phenylephrine base is provided on the overwrapping bag label. MDR Number MDR 198-05/22 Company name Altan Pharma Limited Product description Phenylephrine 0.08 mg/ml -
Class 4 Medicines Defect Information: OxyContin 20 mg prolonged release tablets, EL (22)A/27
Napp Pharmaceuticals Limited have identified an error relating to the Braille printed on the cartons. The Braille message on the Oxycontin 20mg prolonged release tablets incorrectly states strength as 15mg. MDR Number MDR 171-05/22 Company name Napp Pharmaceuticals Limited Product
Class 4 Medicines Defect Information: Orifarm UK Ltd, Loprazolam 1mg Tablets, EL (22)A/25
Orifarm UK have informed us of an error with the Patient Information Leaflet (PIL) packaged within the packs of certain batches. The product name stated in the heading of the PIL has been spelt incorrectly as “lorazolam”, instead of “loprazolam”.
Class 4 Medicines Defect Information: GlaxoSmithKline UK Ltd, Zovirax I.V. 500 mg, EL (22)A/22 updated
GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is inside the sealed pack, and contains unapproved text. MDR Number MDR 191-03/22 Company name GlaxoSmithKline
Class 2 Medicines Recall: Quadrant Pharmaceuticals Ltd, Mefenamic Acid 500mg film coated tablets, EL (22)A/23
Quadrant Pharmaceuticals Ltd are recalling a specific batch of Mefenamic Acid 500mg Film-Coated Tablets as a precautionary measure, due to observations of a defective layer of film coating in some tablets, resulting in the tablet core being partially exposed. MDR
Class 2 Medicines Recall: Crescent Pharma Limited, Paroxetine 40mg Film Coated Tablets, EL(22)A/19
Crescent Pharma Limited are recalling a specific batch of Paroxetine 40mg Film Coated Tablets as a precautionary measure. MDR number MDR 136-03/22 Company name Crescent Pharma Limited Product name Paroxetine 40mg Film Coated Tablets PL 20416/0363 Batch number Expiry date