Class II · Moderate risk Terminated
Telmisartan and Hyrdochlorothiazide Tablets
Reason Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg
Reason Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II · Moderate risk Terminated
Tamsulosin Hydrochloride Capsules
Reason Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Class I · High risk Terminated
Golean DETOX capsules
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the US. The presence of sibutramine and phenolphthalein in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
Class II · Moderate risk Terminated
Gentamicin Sulfate Ophthalmic Solution
Reason Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 17.44-0.64mg-5.8mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 17.44-0.58mg-5.8mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 15-0.25mg-6mcg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 30-1 Mg-20 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 9-1 Mg-10 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 22.5-0.8mg-8.3mcg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 17.64-0.58mg-5.88mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 16.6-0.55 Mg-11.1 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 15-0.5mg-10mcg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 30-2 Mg-30 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine 30-0.5 Mg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine 15-0.5mgmg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Pge1-Lidocaine 40 Mcg-1% /Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 30-1.6 Mg-16 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 23-0.96mg-19.2mcg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 17.16-0.57mg-19.45mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 12-1mg-10mcg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 30-1 Mg-10 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine 30-1 Mg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Pge1 40 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.