Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations:
Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11
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 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.
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
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