OraVerse Injection (2018-04-20)
In plain language
This recall involves OraVerse Injection sold in Canada. It's being recalled because it is out of specification for phentolamine mesylate assay and has out of trend degradation product impurity. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check lot numbers D01894D and D01894F.
- Return the product as instructed.
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Affected products
OraVerse Injection
Lot: D01894D, D01894F
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: D01894D, D01894F
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?
This recall involves OraVerse Injection sold in Canada. It's being recalled because it is out of specification for phentolamine mesylate assay and has out of trend degradation product impurity. Stop using the product and follow the return steps in the official notice.
What should consumers do?
Stop using the product immediately. Check lot numbers D01894D and D01894F. Return the product as instructed.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on April 27, 2018.
Is the OraVerse brand affected by this recall?
Yes, OraVerse products are affected by this recall. This recall involves OraVerse Injection sold in Canada. It's being recalled because it is out of specification for phentolamine mesylate assay and has out of trend degradation product impurity. Stop using the product and follow the return steps in the official notice.