Class I · High risk
Adrucil (fluorouracil injection, USP)
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 recalls, newest first.
Class III · Low risk
Levalbuterol Inhalation Solution
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class II · Moderate risk
Alinia (nitazoxanide)
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Estradiol cream
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Estriol
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Estradiol
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Estradiol
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Tri-Est 80:10:10 Progesterone
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Methyl Folate Lyophilized Powder for Injection
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Artesunate Lyophilized Powder for Injection
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Meloxicam capsules
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Leucovorin Calcium capsules
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Bi-Est 80:20 Progesterone
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class I · High risk
Cytarabine Injection 100 mg/5 mL
Presence of Particulate Matter
Class I · High risk
Bupivacaine Hydrochloride Inj.
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Class II · Moderate risk
Ketorolac Trom 30 Mg/Ml Inj
Crystallization
Class II · Moderate risk
Captopril Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Captopril Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Captopril Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Zonisamide Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.