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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84055

23 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 15, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
8046255 Canada Inc. DBA Viatrexx

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

23 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 23

Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0090, NDC 73069-100-41.

D-0326-2020
Recall number
D-0326-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
24 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00001, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 2 of 23

Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC4020, NDC 73069-347-41.

D-0327-2020
Recall number
D-0327-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
61 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00002, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 3 of 23

Viatrexx-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0500, NDC 73069-402-41.

D-0328-2020
Recall number
D-0328-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
19 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00003, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 4 of 23

Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-270-41.

D-0329-2020
Recall number
D-0329-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
12 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00004, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 5 of 23

Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0008, NDC 73069-024-41.

D-0330-2020
Recall number
D-0330-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
4 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00005, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 6 of 23

Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0665, NDC 73069-500-41.

D-0331-2020
Recall number
D-0331-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
5 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00007, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 7 of 23

Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0031, NDC 73069-037-41.

D-0332-2020
Recall number
D-0332-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
69 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00008, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 8 of 23

Viatrexx-Neuro 3, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0463, NDC 73069-373-41.

D-0333-2020
Recall number
D-0333-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
7 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00010, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 9 of 23

Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0279, NDC 73069-249-41.

D-0334-2020
Recall number
D-0334-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
54 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00012, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 10 of 23

Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0085, NDC 73069-095-41.

D-0335-2020
Recall number
D-0335-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
22 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00014, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 11 of 23

Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0558, NDC 73069-443-41.

D-0336-2020
Recall number
D-0336-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
42 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00016, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 12 of 23

Viatrexx-Lymph 1, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0370, NDC 73069-310-41.

D-0337-2020
Recall number
D-0337-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
3 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00017, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 13 of 23

Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0092, NDC 73069-102-41.

D-0338-2020
Recall number
D-0338-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
7 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00018, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 14 of 23

Viatrexx-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0211, NDC 73069-189-41.

D-0339-2020
Recall number
D-0339-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
3 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00019, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 15 of 23

Viatrexx-Arthros, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0030, NDC 73069-035-41.

D-0340-2020
Recall number
D-0340-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
6 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00021, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 16 of 23

Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0270, NDC 73069-244-41.

D-0341-2020
Recall number
D-0341-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
18 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00023, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 17 of 23

Viatrexx-Relief +, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0615, NDC 73069-450-41.

D-0342-2020
Recall number
D-0342-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00024, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 18 of 23

Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0280, NDC 73069-250-41.

D-0343-2020
Recall number
D-0343-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
8 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00025, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 19 of 23

Viatrexx-Facial, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0184, NDC 73069-164-41.

D-0344-2020
Recall number
D-0344-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
13 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00026, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 20 of 23

Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0251, NDC 73069-206-41.

D-0345-2020
Recall number
D-0345-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
3 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00009, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 21 of 23

Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0460, NDC 73069-375-41.

D-0346-2020
Recall number
D-0346-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
13 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00020, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 22 of 23

Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0400, NDC 73069-320-41.

D-0347-2020
Recall number
D-0347-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00022, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

drug · product 23 of 23

Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0025, NDC 73069-039-41.

D-0348-2020
Recall number
D-0348-2020
Initiated
October 15, 2019
Classification
Class II
Status
Terminated
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information

Lot Numbers: 19-S00027, Exp. May: 2020

Distribution pattern

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

Field note

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