OrfenAce 100 mg tablets recall in Canada: nitrosamine impurity
In plain language
This recall involves OrfenAce 100 mg tablets sold in Canada. It's being recalled because of a nitrosamine impurity. Talk to your healthcare provider for an alternative muscle relaxant and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Seek an alternative muscle relaxant from your healthcare provider.
- Contact SteriMax Inc. at medinfo@sterimaxinc.com or 1-800-881-3550, extension 5, for questions.
- Report any health product-related side effects or complaints to Health Canada.
Get alerts for recalls like this
Get email alerts when new recalls affect products in this category.
Affected products
OrfenAce 100 mg Tablets (Blisters)
Lot: 10025A18, 10025A19, 10025B18
Date codes: Jun 2021, Nov 2021, Sep 2021
OrfenAce 100 mg Tablets (Bottles)
Lot: 36664, 37342, 37384, 38058
Date codes: Jun 2021, Nov 2021, Sep 2021
Why this matters
Potential cancer risk from nitrosamine impurity
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 date code
Date codes are usually printed near the best-before date or on the packaging seam.
Affected date codes: Jun 2021, Nov 2021, Sep 2021
- 3
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 10025A18, 10025A19, 10025B18, 36664, 37342, 37384, 38058
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?
Potential cancer risk from nitrosamine impurity
What should consumers do?
Stop using the product immediately. Seek an alternative muscle relaxant from your healthcare provider. Contact SteriMax Inc. at medinfo@sterimaxinc.com or 1-800-881-3550, extension 5, for questions. Report any health product-related side effects or complaints to Health Canada.
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. Potential cancer risk from nitrosamine impurity
When was this product recalled?
This product was recalled on April 16, 2021.
Is the OrfenAce brand affected by this recall?
Yes, OrfenAce products are affected by this recall. This recall involves OrfenAce 100 mg tablets sold in Canada. It's being recalled because of a nitrosamine impurity. Talk to your healthcare provider for an alternative muscle relaxant and follow the return/repair steps in the official notice.