Class II · Moderate risk Terminated
Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply.
Reason Lack of Processing Controls.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Botox 100 Units Vial NDC 00023-1145-01 90 days supply.
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Altera Handset NDC 83490-0678-05 56 days supply
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Otezla 30 mg tablet NDC 59572-0631-06 30 days supply
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Pulmicort Respules 0.5 mg/2mL s
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Polyethylene Glycol 3350
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Pediasure Liq. Vanilla G+G
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Kalydeco 150 mg tablet blister
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Albuterol 0.083% Inh Sol. 30 days supply
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Humira Pen Sub-q Kit a.) 40 mg/0.8 mL
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
WipeEssentials Wet Wipes
Reason CGMP Deviations: finished products were manufactured with poor quality water.
Class II · Moderate risk Terminated
Acure
Reason CGMP Deviations: finished products were manufactured with poor quality water.
Class II · Moderate risk Terminated
Amantadine HCl Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
PASTA DE LASSAR ANDROMACO Skin Protection
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Zhong Hua Jiu
Reason CGMP Deviations: the product was produced with substandard GMP manufacturing processes.