Yes — there is an active recall. 19 ongoing FDA recalls mention Choline (151 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Choline. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Reason Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Reason Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial…
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility…
Reason Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility…
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Reason Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Reason Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Reason Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Reason Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Reason Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Reason Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Reason CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because…
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…
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