14,801 recalls, newest first
Reason Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Reason Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications.
Reason Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Reason Lack of Assurance of Sterility: Bags have potential to leak.
Reason CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Reason Failed Dissolution Specifications
Reason Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Reason Subpotent Drug
Reason Subpotent Drug
Reason Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Reason Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Reason Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.