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Lack of Assurance of Sterility
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Subpotent Drug
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Dietary supplement may contain potential metal shavings greater than or equal to 7mm in length.
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Failed Dissolution Specifications
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Lack of sterility assurance: leaking bags
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
CGMP deviations
Impurity failure at 0-time of the repackaged lot.