Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105…
Reason Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
458 FDA recalls mention Alcohol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Alcohol.
Reason Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Reason Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial…
Reason Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Reason Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Reason Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Reason Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Reason Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Reason Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Reason Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Reason Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Reason CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of…
Reason Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with…
Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
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