Class II · Moderate risk
Bupivacaine HCl Injection
cGMP deviations: Temperature abuse
FDA Drug Recalls
1,018 recalls, newest first
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.
Class II · Moderate risk
Losartan Potassium 50 mg Tablet
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
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 III · Low risk
Cyanocobalamin Injection
Subpotent Drug: Out of Specification results for Assay
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.
Class II · Moderate risk
NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution
Failed Reconstitution time
Class II · Moderate risk
Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Hydroxocobalamin B12
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated