OPTIRAY 320 Ioversol 135.6 g/200 mL injection vial, Guerbet Australia Pty Ltd, CON-940
Product name
OPTIRAY 320 Ioversol 135.6 g/200 mL injection vial
Sponsor name
Guerbet Australia Pty Ltd
Batches
20F1245, 21H1495 and 21L2255
Consent start
Consent no.
CON-940
Standard
Subsection 9(3) and paragraphs 8(1)(d), 8(1)(e), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(d), 10(2)(a), 10(3)(a), and 10(4)(f) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The products do not conform with the following requirements of subsection 9(3)
and paragraphs 8(1)(d), 8(1)(e), 8(1)(h), 8(1)(i), 8(1)(n), 9(1)(d), 10(2)(a),
10(3)(a), and 10(4)(f) of Therapeutic Goods Order No. 91 - Standard for labels
of prescription and related medicines (TGO 91) in that The vial outer carton
labels (for the 49423 and 49425 products) do not include the
approved name of dosage form; do not include the quantity of the medicine; do
not include the approved storage conditions (i.e., 'Store below 25°C. Do not
Freeze. Protect from light'); do not include the Australian sponsor details; do
not include a machine-readable code; do not include the name of the medicine on
three non-opposing sides; do not include the name of the medicine and the name
and quantity of the active ingredient as a cohesive unit. The vial (hanger)
labels (for the 49423 and 49425 products) do not include the
approved name of dosage form; do not include the approved storage conditions
(i.e., 'Store below 25°C. Do not Freeze. Protect from light'); do not include a
machine-readable code; do not include the name of the medicine and the name and
quantity of the active ingredient as a cohesive unit; do not include the name
and quantity of the excipients; do not include the statement 'Use in one patient
on one occasion only' or words to that effect. The syringe outer carton labels
(for the 46642 product) do not include the approved name of dosage form;
do not include the approved storage conditions (i.e., 'Store below 25°C. Do not
Freeze. Protect from light'); do not include the Australian sponsor details; do
not include a machine-readable code; do not include the name of the medicine on
three non-opposing sides. The syringe labels and the syringe intermediate labels
(for the 46642 product) do not include the approved name of dosage form;
do not include the approved storage conditions (i.e., 'Store below 25°C. Do not
Freeze. Protect from light'); do not include a machine-readable code; do not
include the name and quantity of the excipients; do not include the statement
'Use in one patient on one occasion only' or words to that effect.
Conditions imposed
1. A Dear Healthcare Professional letter identical to that provided with the
application dated 11 May 2022 will be supplied with each affected batch.
2. The will be over-stickered on the carton as advised in the email
correspondence to the Therapeutics Goods Administration dated 13 May 2022.
3. The labels to which this consent applies are those provided with the
application dated 13 May 2022.
Therapeutic product type
Prescription medicines