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Defective container
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Labeling: Label Mix-Up
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Sub Potent
Super Potent
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Product found to be Sub Potent or Exceeded reconstitution time
Super Potent and Failed Reconstitution Time
Lack of Assurance of Sterility