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 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 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 cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Reason Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Reason CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Reason CGMP Deviations
Reason Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Reason Lack of Assurance of Sterility
Reason Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Reason Subpotent Drug
Reason Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined…
Reason Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Reason Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Reason Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Reason Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Reason Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Superpotent and Subpotent; low and high assay results
Reason GMP Deviations
Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
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