Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations
Alprostadil Container Description: Amber color bottle
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 Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Reason Lack of assurance of sterility.
Reason Lack of assurance of sterility.
Reason Lack of assurance of sterility.
Reason Lack of assurance of sterility.
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