Class II · Moderate risk Terminated
Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply
Reason Lack of Processing Controls.
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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.
Class III · Low risk Terminated
24-HOUR Oral Care q4 Kit with Ballard* Technology
Reason Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk Terminated
24-HOUR Oral Care q2 Kit with Ballard* Technology
Reason Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk Terminated
Chlorhexidine Gluconate Oral Rinse
Reason Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class II · Moderate risk Terminated
Conzerol
Reason cGMP Deviations
Class II · Moderate risk Terminated
Molleave
Reason cGMP Deviations
Class II · Moderate risk Terminated
Conzerol zero molluscum contagiosum
Reason cGMP Deviations
Class II · Moderate risk Terminated
Levofloxacin in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class II · Moderate risk Terminated
Levofloxacin in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Class II · Moderate risk Terminated
Levetiracetam in 0.54% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap