Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets 5 mg/160 mg
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Infants' Ibuprofen
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk Terminated
Infants' Ibuprofen
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk Terminated
infants* IBUPROFEN
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan and Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class II · Moderate risk Terminated
Germ Bloc Health Hand Sanitizer Foam
Reason Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 3000 IU
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
FastStat Topical Hemostat Introductory Kit
Reason cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk Terminated
BeeGentle Honey Flavored Topical Anesthetic
Reason cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk Terminated
SHEER DesenZ Desensitizing Treatment
Reason cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk Terminated
fas.TRACT Coagulative Hemostatic Gel
Reason cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk Terminated
Quetiapine Tablets USP 400 mg
Reason Presence of Foreign Substance; metal shard found in tablet
Class II · Moderate risk Terminated
Medi-Stat Foam
Reason Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
Class II · Moderate risk Terminated
Equi-Soft Foam
Reason Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
Class II · Moderate risk Terminated
INFed
Reason Failed Stability Specification: out of specification for iron content.
Class II · Moderate risk Terminated
Clopidogrel Tablets
Reason Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Class II · Moderate risk Terminated
Antacid Tablets
Reason Presence of foreign substance: Product found to contain metal particles.
Class II · Moderate risk Terminated
Curaplex Epi Kit NOT FOR IV USE
Reason Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.