Class II · Moderate risk
Vancomycin PF
Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
FDA Drug Recalls
1,803 recalls · Class II, newest first
Class II · Moderate risk
Bevacizumab 1.25 mg/0.05 mL PF
Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
Class II · Moderate risk
Concentrated Motrin
Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
Class II · Moderate risk
SIH-Testosterone Cypionate 200 mg/mL Injectable
Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory
Class II · Moderate risk
Estradiol 1.25 mg
Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory.
Class II · Moderate risk
Histamine
Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
Sodium Phosphate Injectable
Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
Pge-1
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
Pge-1
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
Testosterone CYP
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
Testosterone Cypionate
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Class II · Moderate risk
0.5% Bupivacaine HCl and Epinephrine 1:200
Lack of Assurance of Sterility; potential for vial breakage
Class II · Moderate risk
Bevacizumab 25mg/mL
Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate.
Class II · Moderate risk
Hydroxocobalamin MDV 5 mg/mL
Lack of Assurance of Sterility: The pharmacy is recalling one lot of Hydroxocobalamin MDV 5mg/mL due to failed sterility results by a third party contract testing lab. Hence the sterility of the product cannot be assured.
Class II · Moderate risk
Aldactone (spironolactone)
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Class II · Moderate risk
Spironolactone tablets
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Class II · Moderate risk
Spironolactone tablets
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Class II · Moderate risk
5% Lidocaine HCl and 7.5% Dextrose Injection
Presence of Particulate Matter; report of visible particulates in the glass ampule
Class II · Moderate risk
Vicks NyQuil Cold and Flu Nighttime Relief
Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.
Class II · Moderate risk
Ibu (NDC 55111-684-05)
Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.
Class II · Moderate risk
Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Class II · Moderate risk
Bevacizumab
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
Hyaluron (hyaluronidase)
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Class II · Moderate risk
Dextrose 50% Preservative Free SDV Injection Solution
Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.