Class II · Moderate risk
Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply
Lack of Processing Controls.
FDA Drug Recalls
1,590 recalls, newest first
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
Class II · Moderate risk
Molleave
cGMP Deviations
Class II · Moderate risk
Conzerol zero molluscum contagiosum
cGMP Deviations
Class II · Moderate risk
Levofloxacin in 5% Dextrose Injection
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
Levofloxacin in 5% Dextrose Injection
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
Levetiracetam in 0.54% Sodium Chloride Injection
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap