Class II · Moderate risk Terminated
Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe
Reason Lack of Sterility Assurance
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Deferoxamine 4 grams/NS 101 mL Cassette
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Deferoxamine 2 grams/51 mL NS cassette
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Daptomycin 650 mg in 50 mL 0.9% NS bag
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
D5 1/2 NS 1000 mL with Electrolytes bag
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Clindamycin 900 mg in 100 mL 0.9% NS bag
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Ceftriaxone 2 gram in 100 mL 0.9% NS bags
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Cefazolin 6 grams in 292 mL 0.9% NS bags
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Ascorbic Acid 500 mg
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
70% Ethanol-lock Solution
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq.
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Oxycodone Hydrochloride Oral Solution
Reason 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 Terminated
Brevibloc DOUBLE STRENGTH Premixed Injection
Reason Discoloration: presence of atypical yellow discoloration of the solution .
Class III · Low risk Terminated
SKY Aspirin Chewable Tablets
Reason Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-release Tablets
Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-release Tablets
Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-release Tablets
Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class II · Moderate risk Terminated
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops
Reason Presence of Particulate Matter
Class III · Low risk Terminated
Haloperidol Decanoate Injection
Reason Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Class III · Low risk Terminated
Lisinopril Tablets USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated
Lisinopril Tablets USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class II · Moderate risk Terminated
Cisatracurium Besylate Injection
Reason 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.