35 FDA recalls mention Acetylcysteine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Acetylcysteine.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the…
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the…
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Reason Lack Of Processing Controls
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Reason Lack of Processing Controls
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Reason CGMP Deviations
Reason Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen…
Reason Lack of Assurance of Sterility
Reason Lack of assurance of sterility
Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an…
Reason Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with…
Reason Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Reason Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
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