40 FDA recalls mention Gentamicin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Gentamicin.
Reason Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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 cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Reason Lack of Processing Controls
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified…
Reason Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Reason Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of sterility assurance.
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