Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
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
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Azithromycin for Injection USP Vial
cGMP deviations: Temperature abuse
Class II · Moderate risk
Topex (benzocaine 20%)
cGMP deviations: Temperature abuse
Class II · Moderate risk
TobraDex (tobramycin and dexamethasone)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Miocol-E (acetylcholine chloride intraocular solution)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Epi-Pen 2-Pak
cGMP deviations: Temperature abuse
Class II · Moderate risk
Losartan Potassium Tab. USP 50mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP deviations: tablets cracking
Class II · Moderate risk
Rifampin for Injection
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Class II · Moderate risk
Losartan Potassium 50 mg Tablet
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk
Trulicity (dulaglutide)
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Class II · Moderate risk
Trulicity (dulaglutide)
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class II · Moderate risk
Kill 'Dat Sanitizing Products Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Class II · Moderate risk
Sermorelin Acetate 1 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PT-141 (Bremelanotide Acetate)
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Melanotan II 1 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
LL-37 2 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Ipamorelin Acetate/Sermorelin Acetate
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
BPC-157 2 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
ARA-290 (Cibinetide Acetate)
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.