Class II · Moderate risk
Testosterone 100mg Anastrozole 4mg
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone Cypionate + Progesterone
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025
Drug: Testosterone
- Recalling firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1040-2017 · FDA notice
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.
Other Testosterone recalls
See all
Class II · Moderate risk
Testosterone 87.5mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 200mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 100mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 75mg
Presence of Foreign substance - potential presence of metal particulate matter
Other recalls by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
All 2017 recalls
Class II · Moderate risk
Zinc Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Cholecalciferol
Lack of Assurance of Sterility
Class II · Moderate risk
Cholecalciferol
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Diacetate Injectable Suspension
Lack of Assurance of Sterility
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