Table 1.

Substandard medicines recalled by the MHRA under class 1 drug alert

Type of defect	Medications	Formulation	Defect description	Time taken for the MHRA to issue drug alerts from the first distribution of defective batches (days)
Substandard medicines
Contamination	Zinc oxide BP 15% w/w	Local preparation	Lack of sterility assurance	19
	Etoposide 20 mg/mL	Injection	Lack of sterility assurance	Not stated
	Paclitaxel 6 mg/mL	Injection	Lack of sterility assurance	Not stated
	Tetrofosmin 230 μg	Injection	Gas filters used in the aseptic manufacturing process were not sterile	33
	Rabies vaccine	Injection	low level of contamination with live attenuated rabies virus	64
	Nelfinavir mesilate	All presentations	Contaminated originator and parallel distributed product	Not stated
Major packaging defects	Ibuprofen	Tablets	The product contained rogue quetiapine XL 50 mg tablets and gabapentin 100 mg capsules	117
	Ephedrine hydrochloride 3 mg/mL	Injection	Ephedrine hydrochloride syringe in a plastic box erroneously identified as atropine sulfate injection	44
	Bendroflumethiazide 2.5 mg	Tablets	This batch contains warfarin 3 mg tablets	210
Delivery issues	Temozolomide*	Capsules	Reports of broken capsules and leakage	38
	Temozolomide*	Capsules	Reports of broken capsules and leakage	91
	Fentanyl (40 μg/dose)	Transdermal system	One batch of the transdermal system have been found to self-activate which has the potential to cause overdose	Not stated
	Salbutamol 100 μg	Inhaler	Fault with the valve which may lead to higher doses	120
Potency issues	Fentanyl compressed lozenge	Compressed lozenge	The potency of the product is out of specification	242
Issues relating to active pharmaceutical ingredient	Oxybutynin hydrochloride 5 mg	Tablets	Excessive amount of active ingredient	56
	Enoxaparin sodium 20 and 40 mg	Injection	Excessive amount of active ingredient	207
Other issues	Protamine sulfate 10 mg/mL	Injection	Failure of the finished product to meet normal assay criteria	13

*Two separate incidents.

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