Vancomycin Hydrochloride Capsules
Subpotent Drug
1,464 recalls · Class II, newest first
Subpotent Drug
Subpotent Drug
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Failed Dissolution Specifications
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Crystallization
Crystallization
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Failed Dissolution Specifications: 6 month time point.
Defective Delivery System: One lot exceeded the mechanical peel specification
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".