359 recalls, newest first
Reason Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Reason Failed Impurities/Degradation Specifications: Related Substances
Reason Subpotent Drug
Reason CGMP Deviations
Reason CGMP Deviations
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Reason Defective Container
Reason Defective Container
Reason Defective Container
Reason CGMP Deviations
Reason Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Reason Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Reason Lack of Assurance of Sterility: Leaking vials
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Reason Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Reason Discoloration: Brownish tablets
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Reason Failed Impurities/Degradation Specifications.
Reason Failed Impurities/Degradation Specifications.
Reason Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered…