Class II · Moderate risk
Amlodipine and Benazapril HCL Capsules
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
FDA Drug Recalls
1,356 recalls, newest first
Class III · Low risk
Class II · Moderate risk
Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
Lack of Processing Controls.
Class II · Moderate risk
Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply
Lack of Processing Controls.
Class II · Moderate risk
Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply
Lack of Processing Controls.
Class II · Moderate risk
Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply
Lack of Processing Controls.
Class II · Moderate risk
Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and…
Lack of Processing Controls.
Class II · Moderate risk
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply
Lack of Processing Controls.
Class II · Moderate risk
Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply
Lack of Processing Controls.
Class II · Moderate risk
Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply
Lack of Processing Controls.
Class II · Moderate risk
Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply
Lack of Processing Controls.
Class II · Moderate risk
Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply
Lack of Processing Controls.
Class II · Moderate risk
Temozolomide 250 mg NDC 43975-0257-05 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Temozolomide 20 mg NDC 43975-0253-05 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Xalkori 250 mg cap NDC 00069-8140-20 30 days supply
Lack of Processing Controls.
Class II · Moderate risk
Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply
Lack of Processing Controls.