Class II · Moderate risk
Dobutamine 2000 mcg/mL in a) D5W-500 mL
Lack of Sterility Assurance.
FDA Drug Recalls
1,103 recalls, newest first
Class II · Moderate risk
Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe
Lack of Sterility Assurance
Class II · Moderate risk
Deferoxamine 4 grams/NS 101 mL Cassette
Lack of Sterility Assurance
Class II · Moderate risk
Deferoxamine 2 grams/51 mL NS cassette
Lack of Sterility Assurance.
Class II · Moderate risk
Daptomycin 650 mg in 50 mL 0.9% NS bag
Lack of Sterility Assurance
Class II · Moderate risk
D5 1/2 NS 1000 mL with Electrolytes bag
Lack of Sterility Assurance
Class II · Moderate risk
Clindamycin 900 mg in 100 mL 0.9% NS bag
Lack of Sterility Assurance
Class II · Moderate risk
Ceftriaxone 2 gram in 100 mL 0.9% NS bags
Lack of Sterility Assurance
Class II · Moderate risk
Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag
Lack of Sterility Assurance
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
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.