Testosterone 3%
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
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.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
Reason cGMP deviation: Product held outside of appropriate temperature storage conditions.
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