Class II · Moderate risk Terminated
Phosphatidylcholine/Deoxycholic Acid
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Is Deoxycholic recalled?
Not under an active recall.
Deoxycholic was recalled 6 times in the past — all now closed. Most recent: Dec 22, 2022.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Deoxycholic. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class II · Moderate risk Terminated
Deoxycholic Acid Sodium Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pho-Tid-Chol 50mg/ Deoxycholic 42 Mg/Ml Inj
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phosphatidylcholine/Deoxycholic Acid- 5%/4.75%
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Phosphatidylcholine/Deoxycholic Acid Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phosphatidylcholine/Deoxycholic Acid 50ml
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
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