921 recalls · Class II, newest first
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.
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.
Failed Dissolution Specifications
Failed Dissolution Specifications
Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Superpotent Drug. Lidocaine higher concentration than listed
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
CGMP deviations.
Failed Dissolution Specifications
Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
cGMP deviations: The firm was notified of the manufacturer's expanded recall.