Class II · Moderate risk
Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply
Lack of Processing Controls.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.
Lack of Processing Controls.
Class II · Moderate risk
Botox 100 Units Vial NDC 00023-1145-01 90 days supply.
Lack of Processing Controls.
Class II · Moderate risk
Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply
Lack of Processing Controls.
Class II · Moderate risk
Altera Handset NDC 83490-0678-05 56 days supply
Lack of Processing Controls.
Class II · Moderate risk
Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98
Lack of Processing Controls.
Class II · Moderate risk
Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Otezla 30 mg tablet NDC 59572-0631-06 30 days supply
Lack of Processing Controls.
Class II · Moderate risk
Pulmicort Respules 0.5 mg/2mL s
Lack of Processing Controls.
Class II · Moderate risk
Polyethylene Glycol 3350
Lack of Processing Controls.
Class II · Moderate risk
Pediasure Liq. Vanilla G+G
Lack of Processing Controls.
Class II · Moderate risk
Kalydeco 150 mg tablet blister
Lack of Processing Controls.
Class II · Moderate risk
Albuterol 0.083% Inh Sol. 30 days supply
Lack of Processing Controls.
Class II · Moderate risk
Humira Pen Sub-q Kit a.) 40 mg/0.8 mL
Lack of Processing Controls.
Class II · Moderate risk
WipeEssentials Wet Wipes
CGMP Deviations: finished products were manufactured with poor quality water.
Class II · Moderate risk
Acure
CGMP Deviations: finished products were manufactured with poor quality water.
Class II · Moderate risk
Amantadine HCl Capsules
Failed Dissolution Specifications
Class II · Moderate risk
PASTA DE LASSAR ANDROMACO Skin Protection
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Zhong Hua Jiu
CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
Class III · Low risk
24-HOUR Oral Care q4 Kit with Ballard* Technology
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk
24-HOUR Oral Care q2 Kit with Ballard* Technology
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk
Chlorhexidine Gluconate Oral Rinse
Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class II · Moderate risk
Conzerol (antipoxin)
cGMP Deviations