Class II · Moderate risk
EPI-Pen Jr
cGMP deviations: Temperature abuse
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Dihydroergotamine Mesylate
cGMP deviations: Temperature abuse
Class II · Moderate risk
Epidural Tray
cGMP deviations: Temperature abuse
Class II · Moderate risk
Ampicillin for Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Betadine 5%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Sumatriptan Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Arzol (Silver Nitrate Applicator)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Olanzapine single dose vial Lyophilized
cGMP deviations: Temperature abuse
Class II · Moderate risk
Lidocaine Patch
cGMP deviations: Temperature abuse
Class II · Moderate risk
Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL
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
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 I · High risk
Insulin Glargine
Labeling: Missing label on the vial
Class III · Low risk
Cyanocobalamin Injection
Subpotent Drug: Out of specification for assay.
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.