Class II · Moderate risk Ongoing
Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited…
Reason CGMP Deviations
Is Fluphenazine recalled?
7 FDA recalls mention Fluphenazine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluphenazine.
Class II · Moderate risk Ongoing
Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for…
Reason Discoloration; Hazy solution found in one vial instead of a clear solution.
Class III · Low risk Terminated
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Fluphenazine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Fluphenazine Decanoate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Ongoing
Fluphenazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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