404 recalls · Class II, newest first
Reason Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Reason Lack of assurance of Sterility: potential product contamination
Reason Lack of assurance of Sterility: potential product contamination
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Reason Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Reason Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Reason Chemical contamination; presence of lead and lithium above specification
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Reason CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Reason CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Reason Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Reason This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Reason Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Reason Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Reason Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility