Ketamine Hydrochloride recall in Canada: labelling and packaging issues
In plain language
This recall involves US-labelled Ketamine Hydrochloride Injection, USP, 500 mg/5 mL (100 mg/mL) sold in Canada. It's being recalled because of differences in concentration and labelling compared to Canadian products, which could lead to incorrect dosing. Healthcare professionals should follow the instructions in the official notice for proper use and dilution.
What to do
- Healthcare professionals should be aware of the higher concentration (100 mg/mL) of this US-labelled product.
- Dosing calculations need to be modified to reflect the higher concentration.
- This new concentration should be added to drug databases.
- Dilute the 100 mg/mL concentration before intravenous injection as recommended in the official notice.
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Affected products
Ketamine Hydrochloride Injection, USP (US Labelled) 500 mg/5 mL (100 mg/mL)
Lot: 10325DD
Why this matters
Risk of incorrect dosing due to concentration differences
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 10325DD
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Risk of incorrect dosing due to concentration differences
What should consumers do?
Healthcare professionals should be aware of the higher concentration (100 mg/mL) of this US-labelled product. Dosing calculations need to be modified to reflect the higher concentration. This new concentration should be added to drug databases. Dilute the 100 mg/mL concentration before intravenous injection as recommended in the official notice.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Risk of incorrect dosing due to concentration differences
When was this product recalled?
This product was recalled on May 6, 2020.