Class II · Moderate risk
Valsartan 320 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
FDA Drug Recalls
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Class II · Moderate risk
Valsartan 80 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Class III · Low risk
Testosterone 200 mg Pellet
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label
Class II · Moderate risk
Valsartan tablets 160 mg
Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Papav 300/Phent 5mg/10mL
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
P/P/P 0.02/40/2mg/mL
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PRO/PA/PH/AT 18mcg/1.8mg/
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PRASH 12.2mcg/1.22m/19.29
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
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.
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.