Why it was recalled
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Product description
Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0031, NDC 73069-037-41.
Lot numbers, UPCs & expiration codes
Lot Numbers: 19-S00008, Exp. May: 2020
Where it was sold
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0332-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 15, 2019
- FDA report date
- Nov 20, 2019
- Quantity
- 69 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- 8046255 Canada Inc. DBA Viatrexx
Original FDA data
Every field from FDA enforcement report D-0332-2020, exactly as published.
Show all FDA fields
- City
- Beloeil
- Status
- Terminated
- Country
- Canada
- Event ID
- 84055
- Address
- 1360 Louis-Marchand St
- Code information
- Lot Numbers: 19-S00008, Exp. May: 2020
- Report date
- Nov 20, 2019
- Product type
- Drugs
- Recall number
- D-0332-2020
- Classification
- Class II
- Recalling firm
- 8046255 Canada Inc. DBA Viatrexx
- Product quantity
- 69 vials
- Termination date
- Dec 10, 2020
- Reason for recall
- Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0031, NDC 73069-037-41.
- Distribution pattern
- Distributed to physicians Nationwide throughout the United States and Puerto Rico.
- Recall initiation date
- Oct 15, 2019
- Initial firm notification
- Press Release
- Center classification date
- Nov 14, 2019