144 alerts

For

Drug alert

  1. Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 55-06/18)

    Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.

  2. Class 4 Medicines Defect Information: Phenobarbital Sodium 30mg/ml Injection (MDR 48-02/19)

    Martindale Pharma has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that the EAN bar code for the following batches is incorrect.

  3. FMD Alert: Class 2 (MDR 123-05/19)

    Medicines have been taken out of the regulated medicines’ supply chain during distribution.

  4. Class 2 Medicines Recall: Paracetamol 500mg Tablets, 1 x 1000 PL 04077/0001 (MDR 13-04/19)

    M & A Pharmachem is recalling the above batches because a small number of pots from each batch have been found to contain discoloured tablets due to fungal contamination.

  5. Class 4 Drug Alert, certain Baxter Potassium Chloride containing intravenous infusions

    Baxter Healthcare Limited has informed us that a quality defect has been identified with the above product where the front panel of a small number of infusion bags was found to be missing the red text.

  6. Class 2 Medicines Recall: Co-amoxiclav 125 mg/31.25 mg/5 ml and 25 mg/62.5 mg/5 ml Powder for Oral Suspension (MDR 24-05/19)

    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.

  7. Class 4 Medicines Defect Information: Prednisolone 5mg Tablets (MDR 61-04/19)

    Genesis Pharmaceuticals Ltd has informed us that there is an error on the Braille for the above batches which means that the strength reads as 1mg instead of 5mg.

  8. Class 4 Medicines Defect Information: Ativan 4mg/1ml Solution for injection (MDR 57-04/19)

    Pfizer Limited has informed us that the text on the carton label for the above product has recently been updated and at this time, the product description on the carton was changed from 10 x 1ml ampoules to 10 x 2ml ampoules.

  9. Class 4 Medicines Defect Information: Chloramphenicol 0.5% W/V Antibiotic Eye Drops (MDR 105-03/19)

    Martindale Pharmaceuticals has informed us of two issues with all unexpired batches of the above product, PL 00156/0109, legal status ‘P’.

  10. Company led drug alert - Nutriflex Omega Special 2500ml PL 03551/0118

    B.

  11. Class 4 Medicines Defect Information: Zoledronic acid 5mg solution for infusion (MDR 51-03/19)

    Ranbaxy (UK) Ltd a Sun Pharmaceutical Company, has informed us that some packs from a batch of Zoledronic acid 5mg solution for infusion contain a Patient Information Leaflet for Temozolomide 180mg Capsules.

  12. Class 2 Medicines recall: Accord Healthcare Limited - Losartan Potassium 50mg Film-coated Tablets, PL 20075/0022 and Losartan Potassium 100mg Film-coated Tablets, PL 20075/0023

    Further to previous recalls of Valsartan and Irbesartan containing products, which were potentially contaminated with N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA), we have become aware of products containing Losartan Potassium that are contaminated with a different nitrosamine, N-nitroso-N-methylamino butyric acid (NMBA). Losartan Potassium containing products from Accord Healthcare Limited are affected and the batches listed above are being recalled.

  13. Drug Alert Class 4: Paracetamol Infusion, Accord. (MDR 07-02/19)

    Accord Healthcare Limited has informed us that there is an error on the portion of the Patient Information Leaflet (PIL) for the Paracetamol Infusion which is intended for Healthcare Professionals.

  14. Class 4 defect information: Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe. (MDR 18-01/19)

    Aguettant Limited has informed the MHRA that there is an error in the Patient Information Leaflet (PIL) for batches of Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe.

  15. Class 2 Medicines recall: Actavis Group PTC EHF - Irbesartan 300mg Film-coated tablets, PL 30306/0108 and Irbesartan / Hydrochlorothiazide 300 / 25mg Film-coated Tablets, PL 30306/0267 (MDR 94-06/18)

    Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).

  16. Class 4 defect information: Amoxicillin 500mg Capsules BP (MDR 92-12/18)

    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.

  17. Class 2 Medicines Recall: Macleods Pharma UK Limited - Irbesartan 150mg Film-coated tablets, PL 34771/0079 (MDR 94-06/18)

    Macleods Pharma UK Limited is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).

  18. Class 2 Medicines Recall: Actavis Group PTC EHF - recall of batches of Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets and Irbesartan/Hydrochlorothiazide 150/12.5mg Film-coated Tablets

    Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).

  19. Class 2 Medicines Recall: Teva UK Limited and Mylan - recall of some Valsartan containing products

    Some valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan are being recalled.

  20. Class 2 Medicines Recall: Ozurdex 700 micrograms intravitreal implant in applicator manufactured by Allergan Pharmaceuticals Ireland (MDR 95-08/18)

    Allergan Pharmaceuticals Ireland is recalling specific batches due to the possibility that a single loose silicone particle of approximately 300 microns in diameter may become detached.

  21. Class 4 defect information: Caspofungin 70mg powder for concentrate for solution for infusion (MDR 11-09/18)

    Cadiasun Pharma GmBH has informed us that there is an error on the patient information leaflet for Caspofungin 70mg powder for concentrate for solution for infusion.

  22. Class 4 defect information: Olmetec 20mg Film Coated Tablets (MDR 12-08/18)

    Daiichi Sankyo UK Limited has informed us that there is an error on the blister foil of specific batches of Olmetec 20mg Film-Coated Tablets

  23. Class 3 Medicines Recall: Sodium Cromoglicate eye drops and Murine Hayfever Relief eye drops (MDR 072-05/17)

    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 bottles.

  24. Class 1 Medicines Recall: Action Now – including out of hours Pharmacy Level Recall

    Pharmacies in the UK are being advised to recall all batches of valsartan containing medicines made by Actavis Group PTC (now Accord) and Dexcel Pharma Ltd due to contamination.

  25. Class 2 Medicines Recall: Fiasp FlexTouch 100 units/mL solution for injection pre-filled pen manufactured by Novo Nordisk (MDR 065-06/18)

    Novo Nordisk is recalling one batch as a precautionary measure due to the presence of particles in a small number of samples.

  26. Class 2 Medicines Recall:Own-brand children’s glycerine and blackcurrant cough syrups manufactured by Bell, Sons & Co.

    Bell, Sons & Co is recalling several batches of own-brand children’s blackcurrant cough syrups due to a small number of reports of mould.

  27. Class 4 medicines defect information: Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU PL 16508/0046

    Kyowa Kirin is advising caution in use for one lot of Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU following the detection of glass particles (EL (18) A/09)

  28. Class 3 Medicines Recall: Latanoprost Timolol Eye drops

    FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing. (EL(18)A/08)

  29. Class 4 medicines defect information: Inhixa solution for injection in pre-filled syringe (EL (18)A/07)

    Caution in Use: Distribute to Pharmacy and Clinic Level.

  30. Class 3 Medicines Recall: Lynparza capsule 50mg (olaparib)

    AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit.

  31. Class 4 Medicines Defect Information: Bleo-Kyowa, powder for solution for injection, 15,000 IU

    Caution in Use - Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)

  32. Class 2 Medicines Recall: Seretide Accuhaler 50 microgram/250 microgram/dose inhalation powder, pre-dispensed

    Glaxo Wellcome UK Limited is recalling one lot of Seretide Accuhaler 50/250mcg because a manufacturing issue has resulted in a small number of units not delivering the full number of doses. (EL (18) A/04)

  33. Class 2 Medicines Recall: Ventolin Accuhaler 200mcg (Salbutamol Sulfate)

    Glaxo Wellcome UK is recalling two Lots of Ventolin Accuhaler 200mcg because a manufacturing issue with these Lots has been identified which has resulted in a small number of units not delivering the full number of doses (EL (18) A/03)

  34. Class 2 Medicines Recall: Magnevist and Omniscan Solutions for injection EL (18) A/02

    Bayer plc and GE Healthcare AS are recalling batches of Magnevist Solution for injection, 0.5mmol/ml, intravenous and Omniscan Solutions for injection 0.5 mmol/ml following a safety review of the gadolinium containing contrast media by the European Medicines Agency (EMA).

  35. Class 2 Medicines Recall: Molipaxin 100 mg capsules (one batch)

    Winthrop Pharmaceuticals UK Limited (trading as Zentiva) is conducting a precautionary recall of a single batch of Molipaxin 100 mg capsules due to a potential issue with the metal detector during manufacture of the batch (EL(18) A/01).

  36. Class 4 Medicines Defect Information: Co-Amoxiclav 1000mg/200mg Powder for Solution (EL (17) A-14)

    Caution in Use: Distribute to Hospital Pharmacy and Ward Level.

  37. Class 4 Medicines Defect Information: BUCCOLAM (midazolam) Oromucosal Solution Pre-filled Syringes

    Caution in Use: Distribute to Pharmacy, Hospital, GP, Dental Practice, Ward and Clinic Level.

  38. Class 2 Medicines Recall: Lipitor (Atorvastatin) 80mg film-coated tablets / Atorvastatin 80mg film-coated tablets, Almus livery

    Pfizer is recalling the above batches as a precaution due to an out of specification result for microbiological testing during routine stability studies on a batch of the product which was not released to the market. (EL (17) A/12)

  39. Class 4 medicines defect information: Kyowa Kirin Bleo-Kyowa® Powder for Solution for Injection 15,000 IU

    Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level

  40. Class 4 medicines defect information: some batches of Gentamicin Sulphate Active Pharmaceutical Ingredient (API)

    Caution in Use: Distribute to Hospital Pharmacy, Ward and Operating Theatre Level

  41. Class 2 Medicines Recall: Xarelto 20 mg film-coated tablets (Rivaroxaban)

    Strathclyde Pharmaceuticals Ltd is recalling a single batch of Xarelto 20mg film-coated tablets (Rivaroxaban) because of reports of rogue blister strips of 15 mg tablets within two packs of 20 mg tablets.

  42. Error with the barcodes on selected batches of 8 medicinal products by Focus Pharmaceuticals - Distribute to Pharmacy and Wholesaler level

    (Focus Pharmaceuticals) Error with the barcodes on selected batches of 8 medicinal products – Class 4 Caution in Use (EL (17)A/08)

  43. Class 3 Medicines Recall: Specific batches of Torrent Dutor (Duloxetine) Gastro-resistant Capsules

    Torrent Pharma (UK) Ltd is recalling the below batches as a precaution because out of specification results for dissolution were obtained during routine stability testing.

  44. Class 2 Medicines Recall: Sodium Cromoglicate 2% w/v 13.5 mL Eye Drops

    FDC International Ltd is recalling the batches listed below as a precautionary measure due to a precipitate observed in the bottles.

  45. Class 2 Medicines Recall: Diclo-SR 75 Tablets (Diclofenac Sodium)

    Strides Pharma UK Ltd, trading as Co-pharma, is recalling specific batches of Diclo-SR 75 Tablets as a precautionary measure

  46. Precautionary recall of Viridal Duo Powder and Solvent for Injection (EL (17)A/04)

    Class 2 Medicines recall: UCB Pharma Limited are voluntarily recalling Viridal Duo Powder and Solvent for Injection (10mcg/ml and 40mcg/ml)

  47. Alka-Seltzer Original & Alka-Seltzer XS - recall of some batches due to an issue with the blister foil

    (Bayer plc) Remaining stock of affected batches should be quarantined for uplift by Bayer - class 3 action within 5 days (EL (17)A/03)

  48. Class 4 Caution in Use : Mirena 20 micrograms / 24 hours intrauterine delivery system

    Bayer plc has informed us that they have received two complaints globally concerning Mirena inserters with an insertion tube which is mounted inversely to the handle

  49. Class 4 Caution in Use: Arava 10mg film-coated tablets (Leflunomide)

    Sanofi has informed us that there is an error in the Braille on some batches of Arava 10mg film-coated tablets (EL (17)A/01)

  50. Class 4 Caution in Use: Amoxicillin Sugar Free Suspension 250mg/5ml & Amoxicillin Sugar Free Suspension 125mg/5ml

    Medreich has provided handling instructions following several complaints that the child-resistant caps are difficult to open (EL(16)A/17)