Medicine recalls
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| Canada: Solu-Cortef (hydrocortisone sodium succinate for injection) 100 mg/2 mL single-dose Act-O-Vial - Recalled lots due to potential for dosing error |
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Pfizer Canada is recalling 8 lots of Solu-Cortef (hydrocortisone sodium succinate for injection) 100 mg/2 mL single-dose Act-O-Vial as a result of a labelling text error on the side panel of the carton which indicates that the reconstituted product contains 125 mg /mL hydrocortisone instead of 50 mg/mL. The affected lots numbers are L42719, L58373, L58374, M41003, M63458, N15764, N54056, and N62805. This could lead to a potential dosing error.
This labelling error on the carton has resulted in a product recall which in turn has generated a supply shortage of the product. Solu-Cortef 250 mg/2mL or 500mg/4mLAct-O-vials (single use) can be used as alternatives however, healthcare professionals need to be aware that the alternative products have a reconstituted concentration of 125 mg/mL. Changes to the volume for dosing will be required. Healthcare professionals should inform and instruct patients on how to appropriately use the correct volume of the alternate vial strength of Solu-Cortef or any alternative product.
Solu-Cortef for injection is indicated for the treatment of multiple diseases, disorders and medical conditions, including medical emergencies such as shock secondary to adrenocortical insufficiency. This product may be administered by intravenous injection, intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Solu-Cortef should be reserved for emergency use only until the shortage situation has been resolved. Therapeutic alternatives should be considered for non-urgent medical uses.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../59664a-eng.php
In Hong Kong, Solu Cortef 100mg Act-O-Vial Sterile (HK-00471) is a pharmaceutical product registered by Pfizer Corporation Hong Kong Limited (Pfizer), and is a prescription only medicine. So far, the Department of Health (DH) has not received any adverse drug reaction report related to the product. As confirmed with Pfizer, the affected batches have not been imported into Hong Kong.
Ends/ Wednesday, August 03, 2016
Issued at HKT 15:00
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