Class I · High risk Terminated
Norepinephrine 4 mg
Reason Subpotent Drug: Product may not have the active ingredient present in the bag.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Ethosuximide Capsules
Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Class II · Moderate risk Terminated
Thyroid Powder
Reason CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk Terminated
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets
Reason CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Class II · Moderate risk Terminated
Cortaid 12-Hour Advanced Anti-itch Cream
Reason CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class II · Moderate risk Terminated
Cortaid Maximum Strength Cream
Reason CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class II · Moderate risk Terminated
Cortaid Intensive Therapy Cooling Spray
Reason CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class III · Low risk Terminated
Morphine Sulfate Extended-Release Tablets
Reason Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
Class I · High risk Terminated
Respitrol
Reason Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I · High risk Terminated
Thyroveev
Reason Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I · High risk Terminated
Neuroveen
Reason Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I · High risk Terminated
Compulsin
Reason Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class II · Moderate risk Terminated
Children s Advil Suspension Ibuprofen Oral Suspension
Reason Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Class II · Moderate risk Terminated
Cefuroxime 10mg/mL INJ 0.5 mg
Reason Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
Class II · Moderate risk Terminated
Thyroid Powder USP
Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk Terminated
Thyroid Powder USP
Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class I · High risk Terminated
Hydrochlorothiazide Tablets USP
Reason Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Class II · Moderate risk Terminated
Methyl-Cobalamin injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Folic Acid injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Testosterone Enanthate/Cypionate injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Testosterone Cypionate/Enanthate injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Testosterone Cypionate/Enanthate injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Methyl-Cobalamin injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Methyl-Cobalamin injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Methyl-Cobalamin injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.