Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Cromolyn sodium 1% inhalant solution packaged in a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
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 deviation: product released prior to supplier approval.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations:
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Reason CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
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