Class II · Moderate risk
Amlodipine Besylate and Benazepril HCl Capsules
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
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
Amlodipine Besylate Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
Oxycodone and Acetaminophen Tablets
Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.
Class II · Moderate risk
Ifosfamide Injection 3g/60 mL
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Class II · Moderate risk
Ifosfamide Injection 1g/20mL
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Class II · Moderate risk
Risperdal CONSTA
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
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.
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