Class II · Moderate risk Terminated
P/P/P
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Acetylcysteine 10% Oph Solution
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Medroxprogesterone 1% Ophthalmic Solution
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Vitamin D3 Injection
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Dehydrated Alcohol Solution
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Morphine Sulf inhalation
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Pr/Pa/Ph
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Triple P
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Avastin 1.25 mg/0.05 mL prefilled syringe
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
DMSO 6.25% Opth Sol
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Atropine 0.01% Opth Solution
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+
Reason Microbial Contamination of a Non-Sterile Product
Class II · Moderate risk Terminated
Dymista
Reason Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class II · Moderate risk Terminated
10 mg/mL Rocuronium Bromide
Reason CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk Terminated
5 mg/mL Ephedrine Sulfate
Reason CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk Terminated
10 mcg/mL Fentanyl Citrate
Reason CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Class II · Moderate risk Terminated
Prednisolone Sodium Phosphate Oral Solution
Reason Defective Container: Tamper Evident foil seal not completely intact.
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason Failed Dissolution Specifications:
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason Failed Dissolution Specifications:
Class II · Moderate risk Terminated
AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.