Class II · Moderate risk Ongoing
Testosterone 100mg Anastrozole 4mg
Reason Presence of Foreign substance - potential presence of metal particulate matter
Testosterone USP 99.5%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
What was recalled
Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013
- Recalling firm
- Qualgen
- NDC code
- 69761-125-01
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0387-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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Class II · Moderate risk Ongoing
Testosterone 87.5mg
Reason Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone 200mg
Reason Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone 100mg
Reason Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk Ongoing
Testosterone 75mg
Reason Presence of Foreign substance - potential presence of metal particulate matter
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