Class III · Low risk
Prednisone Tablet USP
Labeling: Missing Label; missing label on blister card
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
Medroxyprogesterone acetate
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Class II · Moderate risk
ChloraPrep With Tint
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
Class I · High risk
Bethel 30 capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
VECURONIUM Bromide for Injection
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
Class II · Moderate risk
Parsel Plus
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
No Doz
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
Excedrin Migraine
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
Excedrin Extra Strength
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Class II · Moderate risk
VersaPharm Incorporated
Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.
Class II · Moderate risk
Cleocin Phosphate
Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
Class III · Low risk
Fentanyl Transdermal System
Failed Impurities/Degradation Specifications
Class III · Low risk
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate)
Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.
Class III · Low risk
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate)
Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.
Class III · Low risk
Norpace CR
Failed Dissolution Specification
Class I · High risk
Calcium Chloride Preservative Free Sterile injection
Non-Sterility: The firm's contract testing laboratory found sterility failures.
Class III · Low risk
Pharmalucence Kit for the Preparation of Technetium Tc 99m…
Presence of Particulate Matter; particulate found in retain samples
Class II · Moderate risk
Cefazolin
Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.
Class II · Moderate risk
Actiq (oral transmucosal fentanyl citrate)
Failed Dissolution Specification; during stability testing