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Undeclared milk from Contains statement.
Undeclared milk and soy (from soy lecithin) from sub-ingredients.
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
cGMP Deviations
Failed Dissolution Specifications: low dissolution results
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
CGMP Deviations; particulates identified during visual inspection
Failed Dissolution Specifications.
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Sub-Potent Drug: Subpotent assay results during stability testing.
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.