Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Failed Impurities/Degradation Specifications
Labeling: Wrong Barcode
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Presence of Particulate Matter: Potential for black particulates in the drug product.
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Discoloration: Dotted and yellow spots on tablets
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Subpotent drug
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.