Class II · Moderate risk
Testosterone 100mg Anastrozole 4mg
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone Cyp 200 mg/mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183
Drug: Testosterone
- Recalling firm
- Medaus, Inc.
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1048-2013 · 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 Medaus, Inc.
All 2013 recalls
Class II · Moderate risk
HCL 2mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Zinc So4 1mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Arginine 100mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Zinc So4 10mg/Ml
Lack of Assurance of Sterility
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