Class II · Moderate risk Completed
Cromolyn Sodium Oral Solution
Reason CGMP deviation: product released prior to supplier approval.
Cromolyn Sodium Ophthalmic Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
What was recalled
Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
- Recalling firm
- Akorn, Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0797-2023
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.
Other Cromolyn recalls
See all
Class II · Moderate risk Ongoing
Cromolyn Sodium Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Terminated
C-Cromolyn Sod 20 Mg/2 Ml Inhalation Solution
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
NasalCrom
Reason CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Class II · Moderate risk Terminated
Cromolyn sodium 1% inhalant solution packaged in a 3 mL or 7 mL vial
Reason 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.
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