SEPTRIN sugar-free oral liquid bottle, Arrow Pharmaceuticals Pty Ltd, CON-938
Product name
SEPTRIN sugar-free oral liquid bottle
Sponsor name
Arrow Pharmaceuticals Pty Ltd
Batches
911803, 915472, 926133, 934351 934352
Consent start
Consent no.
CON-938
Standard
The USP monograph for Sulfamethoxazole and Trimethoprim Oral Suspension.
Non-compliance with standard
The product does not conform to the requirements of the USP monograph for
Sulfamethoxazole and Trimethoprim Oral Suspension, in that the product(s) do not
meet the USP drug product monograph acceptance criteria for Any other
unspecified degradation product of NMT 0.2%.
Conditions imposed
A 'Dear Healthcare Provider' letter identical to that provided to the
Therapeutic Goods Administration on 03 May 2022 will be supplied with each
affected batch requesting that the Product is to be used immediately or before
April 2023 and that the shelf life will be reduced to 18 months.
Therapeutic product type
Prescription medicines