557 recalls, newest first
Reason CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason Defective container: lack of seal integrity.
Reason Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Reason Presence of foreign substance: plastic-like substance.
Reason Presence of Foreign Substance: metal in tablet
Reason Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count…
Reason Failed Impurities/Degradation Specifications
Reason Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Reason Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
Reason Labeling: Wrong Barcode
Reason Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Reason Presence of Particulate Matter: Potential for black particulates in the drug product.
Reason Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Reason Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Reason Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Reason Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Reason Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Reason Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.