165 recalls · Class III, newest first
Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.
Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Chemical Contamination
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
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
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
Labeling: Incorrect or Missing Lot and/or Exp Date
Failed dissolution specifications - low dissolution results at S3 stage.
Failed dissolution specifications - low dissolution results at S3 stage.
Failed dissolution specifications - low dissolution results at S3 stage.
Failed dissolution specifications - low dissolution results at S3 stage.