💊 Drugs • 12,141 recalls
AstraZeneca Pharmaceuticals
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Lack of Assurance of Sterility
Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
Lack of Assurance of Sterility
Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
American Pharmaceutical Ingredients
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Xttrium Laboratories
CGMP Deviations
Cross Contamination With Other Product: Imipramine
Lack of Assurance of Sterility
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
Lantheus MI Radipharmaceuticals
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Apothecary By Design
Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
Superpotent Drug: high out-of-specification result for magnesium.