L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Class I - Dangerous
Lack of Assurance of Sterility
💊
Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Class I - Dangerous
Lack of Assurance of Sterility
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class I - Dangerous
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products.
Class I - Dangerous
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Class I - Dangerous
Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.
Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01
Teva Pharmaceuticals USA
Class I - Dangerous
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Class I - Dangerous
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.