Class II · Moderate risk Terminated
Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Viatrexx-Collagen
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
What was recalled
Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0085, NDC 73069-095-41.
- Recalling firm
- 8046255 Canada Inc. DBA Viatrexx
- NDC code
- 73069-095-41
- Origin
- N/A, Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0335-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Collagen recalls
See all
Class II · Moderate risk Terminated
Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm
Reason Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Class II · Moderate risk Terminated
Collagenase 250 units/ml
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Completed
Tatiomax
Reason Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Class II · Moderate risk Completed
Laroscorbine Platinium
Reason Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
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