ALLMERCAP mercaptopurine monohydrate 20mg/mL oral liquid suspension bottle, Link Medical Products Pty Ltd T A Link Pharmaceuticals, CON-1236
Product name
ALLMERCAP mercaptopurine monohydrate 20mg/mL oral liquid suspension bottle
Sponsor name
Link Medical Products Pty Ltd T A Link Pharmaceuticals
Consent start
Consent no.
CON-1236
Standard
Paragraphs 8(1)(a) and 9(1)(a), Paragraphs 8(1)(b) and 9(1)(b), Subparagraph 8(1)(j)(iv)(A), Paragraph 9(3)(a), Paragraph 8(1)(i), Paragraph 10(4)(j), Subsection 11(5) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) will be supplied in the UK approved packaging which has the
following differences: the name Xaluprine in place of Allmercap; the active
ingredient name is referred to as mercaptopurine instead of mercaptopurine
monohydrate; the name and quantity of the active ingredient are not in a
cohesive unit with the name of the medicine; the storage statement is not in the
permitted format; the Schedule 1 substances are not expressed as required; the
sponsors name and address are not included on the label and the name of the
sponsor is not included on the bottle label
Conditions imposed
1. A 'Dear Healthcare Provider' letter identical to that provided to the TGA on
26 April 2024 will be supplied with each affected batch describing the
differences in the labels.
2. Sponsor details will be attached to the labels in such a way as to not impact
any other relevant information on the labels.
Therapeutic product type
Prescription medicines