1,739 recalls · Class I, newest first
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Reason Failed Content Uniformity Specifications
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Reason Presence of Particulate Matter: Silicone
Reason Presence of Particulate Matter: Silicone
Reason Presence of Particulate Matter: Silicone
Reason Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product…
Reason Presence of Particulate Matter: identified as glass.
Reason Presence of Particulate Matter: identified as glass.
Reason Presence of Particulate Matter: identified as glass.
Reason Microbial contamination of Non-Sterile Products
Reason Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial…
Reason Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Reason Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Reason Non-Sterility
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product…