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.
Collagenase 250 units/ml
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
What was recalled
Collagenase 250 units/ml, Sterile, Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
- Recalling firm
- The Compounding Pharmacy of America
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1455-2015
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
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Class II · Moderate risk Terminated
Viatrexx-Collagen
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
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 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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