Class II · Moderate risk
ChloraPrep With Tint
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
Sodium Bicarbonate Powder
Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
Class II · Moderate risk
VECURONIUM Bromide for Injection
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
Class II · Moderate risk
Parsel Plus
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
No Doz
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
Excedrin Migraine
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
Excedrin Extra Strength
Defective container: products are packaged in pouches which may not have been fully sealed
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Class II · Moderate risk
VersaPharm Incorporated
Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.
Class II · Moderate risk
Cleocin Phosphate
Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.
Class II · Moderate risk
Cefazolin
Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.
Class II · Moderate risk
Yohimbine 10 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Xylazine 300 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Voriconazole 5% Ophthalmic drop compounded by Olympia Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Vitamin B-Buildup Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Vitamin B12 Cyanocobalamin 5000 mcg Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Vitamin B12
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Vitamin A/D3/E Olive Oil Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Vitamin 15
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Tripelennamine 20 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Trimix
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes