6 FDA recalls mention Cromolyn. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cromolyn.
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.
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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