Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 50484-010-30
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
6 FDA recalls mention Collagen. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Collagen.
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 Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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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