Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in…
Lack of Assurance of Sterility; media fill failure at manufacturer
FDA drug recalls in 2017
Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 recalls, newest first.
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Succinylcholine Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Timolol-Brimonidine-Dorzolamide-Latanoprost
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Timolol-Latanoprost PF Solution
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Latanoprost PF Solution
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Curcumin Emulsion 10mg/ml Injection
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class III · Low risk
Paroxetine Extended-Release Tablets USP
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Class II · Moderate risk
Potassium Phosphate
Lack of Assurance of Sterility
Class II · Moderate risk
Potassium Phosphate
Lack of Assurance of Sterility
Class II · Moderate risk
Potassium Phosphate
Lack of Assurance of Sterility
Class II · Moderate risk
QUELICIN (Succinylcholine Chloride)
Lack of Assurance of Sterility
Class I · High risk
MAN OF STEEL capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Class II · Moderate risk
Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol
Lack of sterility assurance
Class II · Moderate risk
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol
Lack of sterility assurance
Class II · Moderate risk
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol
Lack of sterility assurance
Class II · Moderate risk
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol
Lack of sterility assurance
Class II · Moderate risk
Cyclobenzaprine HCl Tablets
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Class II · Moderate risk
Amantadine HCl Capsules
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Class II · Moderate risk
Succinylcholine Chloride
Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier
Class II · Moderate risk
Ibuprofen Tablets
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Class III · Low risk
Amitriptyline HCl Tablets
Cross Contamination With Other Product: Imipramine
Class II · Moderate risk
Clindamycin Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Clindamycin Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
Clindamycin Injection USP
Lack of Assurance of Sterility