All lots of Renadyl probiotic capsules recalled due to undeclared ingredient and missing safety warnings on the label
- Starting date:
- June 7, 2021
- Type of communication:
- Advisory
- Subcategory:
- Natural health products
- Source of recall:
- Health Canada
- Issue:
- Allergy Information, Important Safety Information
- Audience:
- General Public
- Identification number:
- RA-75759
Last updated: 2021-06-07
June 7, 2021
For immediate release
Summary
- Products: Renadyl probiotic capsules, NPN 80036014
- Issue: Gelda Scientific and Industrial Development Corporation is recalling all lots of Renadyl because the product contains undeclared inulin and important safety warnings are missing from the product label.
- What to do: Stop using this product if you have an allergy to inulin or an immune-compromised condition. Talk to a healthcare provider if you have taken a recalled product and have concerns about your health, or for advice on alternatives.
Issue
Gelda Scientific and Industrial Development Corporation is recalling all lots of Renadyl probiotic capsules because the product contains undeclared inulin and important safety warnings are missing from the product label. Renadyl is a probiotic indicated for adult use only.
Inulin can be dangerous for those with inulin allergies. In rare cases, anaphylaxis can occur. Symptoms of anaphylaxis include breathing difficulties, which can be life threatening.
In addition, the following risk statements are missing from the product label:
- Consult a health care practitioner prior to use if you have nausea, fever, vomiting, bloody diarrhea or severe abdominal pain
- Discontinue use and consult a health care practitioner if symptoms of digestive upset (e.g. diarrhea) occur, worsen, or persist beyond 3 days
- Do not use if you have an immune-compromised condition (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment).
These risk statements are important, especially for those who are immune-compromised as they may be at risk of developing infections after taking probiotics.
The affected products were distributed nationally.
Affected products
| Product | NPN | Lot | Expiry |
|---|---|---|---|
| Renadyl probiotic capsules | 80036014 | 5421119B | 31-Oct-2021 |
| 5420320A | 31-Jan-2022 | ||
| 5420720B | 30-Jun-2022 | ||
| 5420820 | 22-Jul-2022 | ||
| 5420221B | 31-Jan-2023 |
What you should do
- Stop using this product if you have an allergy to inulin or an immune-compromised condition, such as AIDS or lymphoma (cancer), or if you're undergoing long-term corticosteroid treatment.
- Talk to a healthcare provider if you have taken a recalled product and have concerns about your health, or for advice on alternatives.
- Contact Gelda Scientific and Industrial Development Corporation at mail@gelda.com or by calling 905-673-9320 if you have questions about the recall.
- Report any health product-related side effects or complaints to Health Canada.
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