2,277 recalls · Class II, newest first
Reason CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Reason Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified…
Reason Failed Impurities/Degradation Specifications:
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Reason Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Reason cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning…
Reason cGMP deviations: Product made at the same facility where product tested was sub-potent.
Reason cGMP deviations: Product made at the same facility where product tested was sub-potent.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.