Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of sterility assurance.
Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
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 CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason cGMP Deviations; lack of quality assurance.
Reason cGMP Deviations: lack of quality assurance at the API manufacturer.
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Reason cGMP Deviations; lack of quality assurance.
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