Table 1

Substandard medicines recalled by the MHRA under class 1 drug alert

Type of defectMedicationsFormulationDefect descriptionTime taken for the MHRA to issue drug alerts from the first distribution of defective batches (days)
Substandard medicines
ContaminationZinc oxide BP 15% w/wLocal preparationLack of sterility assurance 19
Etoposide 20 mg/mLInjectionLack of sterility assuranceNot stated
Paclitaxel 6 mg/mLInjectionLack of sterility assuranceNot stated
Tetrofosmin 230 μgInjectionGas filters used in the aseptic manufacturing process were not sterile 33
Rabies vaccineInjectionlow level of contamination with live attenuated rabies virus 64
Nelfinavir mesilateAll presentationsContaminated originator and parallel distributed productNot stated
Major packaging defectsIbuprofenTabletsThe product contained rogue quetiapine XL 50 mg tablets and gabapentin 100 mg capsules117
Ephedrine hydrochloride 3 mg/mLInjectionEphedrine hydrochloride syringe in a plastic box erroneously identified as atropine sulfate injection 44
Bendroflumethiazide 2.5 mgTabletsThis batch contains warfarin 3 mg tablets210
Delivery issuesTemozolomide*CapsulesReports of broken capsules and leakage 38
Temozolomide*CapsulesReports of broken capsules and leakage 91
Fentanyl (40 μg/dose)Transdermal systemOne batch of the transdermal system have been found to self-activate which has the potential to cause overdoseNot stated
Salbutamol 100 μgInhalerFault with the valve which may lead to higher doses120
Potency issuesFentanyl compressed lozengeCompressed lozengeThe potency of the product is out of specification242
Issues relating to active pharmaceutical ingredientOxybutynin hydrochloride 5 mgTabletsExcessive amount of active ingredient 56
Enoxaparin sodium 20 and 40 mgInjectionExcessive amount of active ingredient207
Other issuesProtamine sulfate 10 mg/mLInjectionFailure of the finished product to meet normal assay criteria 13
  • *Two separate incidents.

  • BP, British pharmacopoeia; MHRA, Medicines and Healthcare Products Regulatory Agency.