4 FDA recalls mention Diflorasone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Diflorasone.
Reason Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason Presence of Foreign Substance: Foreign particles observed during routine stability testing.
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