11 FDA recalls mention Monobasic. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Monobasic.
Reason Product found to be Sub Potent or Exceeded reconstitution time
Reason cGMP deviations
Reason cGMP deviations
Reason Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
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