Class II · Moderate risk
Ascorbic Acid 500 mg
Lack of Sterility Assurance
FDA drug recalls in 2016
Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,199 recalls, newest first.
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
Class I · High risk
PHENYLephrine 1 mg/10 mL
Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.
Class II · Moderate risk
Ondansetron Tablets USP
Failed Impurities/Degradation Specifications; 12 month stability time point