Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External…
Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
123 FDA recalls mention Beta. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Beta.
Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Reason Lack of Processing Control
Reason Lack of Processing Control
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Defective delivery system; product is not foaming or is coming out as liquid.
Reason Defective delivery system; product is not foaming or is coming out as liquid.
Reason Lack of Assurance of Sterility
Reason Temperature Abuse: Complaints received of liquidy texture.
Reason Failed Impurities/Degradation Specifications
Reason Lack of sterility assurance.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals…
Reason Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Reason Defective Container; complaints of leakage.
Reason Lack of sterility assurance.
Reason Lack of Assurance of Sterility
Reason Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date…
Reason Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Failed Content Uniformity Specifications
Reason Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic…
Reason Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a…
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
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