Class II · Moderate risk
Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags
Lack of Sterility Assurance
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Cefazolin 6 grams in 292 mL 0.9% NS bags
Lack of Sterility Assurance
Class II · Moderate risk
Ascorbic Acid 500 mg
Lack of Sterility Assurance
Class II · Moderate risk
70% Ethanol-lock Solution
Lack of Sterility Assurance
Class II · Moderate risk
1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq.
Lack of Sterility Assurance.
Class II · Moderate risk
0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags
Lack of Sterility Assurance
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Class II · Moderate risk
Brevibloc DOUBLE STRENGTH Premixed Injection
Discoloration: presence of atypical yellow discoloration of the solution .
Class III · Low risk
SKY Aspirin Chewable Tablets
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Class III · Low risk
BuPROPion Hydrochloride Extended-release Tablets
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk
BuPROPion Hydrochloride Extended-release Tablets
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk
BuPROPion Hydrochloride Extended-release Tablets
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class II · Moderate risk
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops
Presence of Particulate Matter
Class III · Low risk
Haloperidol Decanoate Injection
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Class III · Low risk
Lisinopril Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Lisinopril Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class II · Moderate risk
Cisatracurium Besylate Injection
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
Class III · Low risk
Lisinopril & Hydrochlorothiazide Tables
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class II · Moderate risk
Better Braids Un-Braid
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
Class I · High risk
Human Chorionic Gonadotropin
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
Class III · Low risk
¿Topicort (desoximetasone)
Subpotent Drug
Class II · Moderate risk
LGD-Xtreme
Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Intermezzo
Failed Dissolution Specifications