CLASS II Drug recall · Reported 20 Nov 2019 · FDA Enforcement Report
Viatrexx-Intra-Cell Sterile multi-dose vial recalled by 8046255 Canada
8046255 Canada is recalling Viatrexx-Intra-Cell Sterile multi-dose vial, distributed nationwide in the US. The recall was initiated on 15 Oct 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0343-2020
- FDA event ID
- 84055
- Recalling firm
- 8046255 Canada, Beloeil, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Oct 2019
- FDA classified
- 14 Nov 2019
- Reported
- 20 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Oct 2019 | Recall initiated by company | |
| 14 Nov 2019 | Classified by FDA | +30 days |
| 20 Nov 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0280, NDC 73069-250-41.
Where it was distributed
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
Questions about this recall
Is Viatrexx-Intra-Cell Sterile multi-dose vial recalled?
Yes. 8046255 Canada recalled Viatrexx-Intra-Cell Sterile multi-dose vial on 15 Oct 2019. The recall is Class II and its status is Terminated. Recall number D-0343-2020.
Why was it recalled?
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Which lots are affected?
Lot Numbers: 19-S00025, Exp. May: 2020
Where was it sold?
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from 8046255 Canada
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Viatrexx-Adipose Sterile multi-dose vial recalled by 8046255 Canada | 8046255 Canada | Sterility | Nationwide |
| Drug | CLASS II | Viatrexx-Male+ Sterile multi-dose vial recalled by 8046255 Canada | 8046255 Canada | Sterility | Nationwide |
| Drug | CLASS II | Viatrexx-Neuro Sterile multi-dose vial recalled by 8046255 Canada | 8046255 Canada | Sterility | Nationwide |
| Drug | CLASS II | Viatrexx-Systemic Detox Sterile multi-dose vial recalled | 8046255 Canada | Sterility | Nationwide |
| Drug | CLASS II | Viatrexx-Relief + Sterile multi-dose vial recalled by 8046255 Canada | 8046255 Canada | Sterility | Nationwide |