Recalls / Class II
Class IID-0335-2020
Product
Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0085, NDC 73069-095-41.
- Affected lot / code info
- Lot Numbers: 19-S00014, Exp. May: 2020
Why it was recalled
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Recalling firm
- Firm
- 8046255 Canada Inc. DBA Viatrexx
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1360 Louis-Marchand St, N/A, Beloeil, N/A N/A, Canada
Distribution
- Quantity
- 22 vials
- Distribution pattern
- Distributed to physicians Nationwide throughout the United States and Puerto Rico.
Timeline
- Recall initiated
- 2019-10-15
- FDA classified
- 2019-11-14
- Posted by FDA
- 2019-11-20
- Terminated
- 2020-12-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0335-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.