Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Discoloration; Hazy solution found in one vial instead of a clear solution.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ
Drug: Fluphenazine
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
Subpotent Drug: Out of specification for assay
Presence of Particulate Matter: Piece of metal found in a vial
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
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