1,058 recalls, newest first
cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before that specific lot was formally qualified for use by the manufacturing site.
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Subpotent
Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
Defective Delivery System: Out of specification for mechanical peel.
Defective Delivery System: Out of specification for mechanical peel.
Defective Delivery System: Out of specification for mechanical peel.
Defective Delivery System: Out of specification for mechanical peel.
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Crystallization: customer complaints for crystallization in finished product.
Crystallization: customer complaints for crystallization in finished product.
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Lack of Assurance of Sterility
Failed Dissolution Specifications
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.