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CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
Incorrect product formulation: bag did not contain copper and famotidine per label.
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Labeling: Incorrect or Missing Lot and/or Exp Date
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
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