Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Collagenase 250 units/ml, Sterile, Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
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.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Reason Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of…
Reason Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
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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