Class II · Moderate risk
P/P/P (Prostaglandin/Papaverine/Phentolamine)
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
FDA Drug Recalls
982 recalls · Class II, newest first
Class II · Moderate risk
Acetylcysteine 10% Oph Solution
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Medroxprogesterone 1% Ophthalmic Solution
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Vitamin D3 Injection
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Dehydrated Alcohol Solution
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Morphine Sulf inhalation
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PR/PA/PH (Prostaglandin/Papaverine/Phentolamine)
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Triple P (Prostaglandin/Papaverine/Phentolamine)
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Avastin 1.25 mg/0.05 mL prefilled syringe
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
DMSO 6.25% Opth Sol
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Atropine 0.01% Opth Solution
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+
Microbial Contamination of a Non-Sterile Product
Class II · Moderate risk
Dymista (azelastine hydrochloride and fluticasone propionate)
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class II · Moderate risk
10 mg/mL Rocuronium Bromide
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk
5 mg/mL Ephedrine Sulfate
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk
10 mcg/mL Fentanyl Citrate
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk
Prednisolone Sodium Phosphate Oral Solution
Defective Container: Tamper Evident foil seal not completely intact.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specifications:
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specifications:
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.