Class II · Moderate risk Terminated
TobraDex
Reason cGMP deviations: Temperature abuse
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Miocol-E
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Epi-Pen 2-Pak
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Losartan Potassium Tab. USP 50mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk Terminated
Pantoprazole Sodium Delayed-Release Tablets
Reason CGMP deviations: tablets cracking
Class II · Moderate risk Terminated
Rifampin for Injection
Reason Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Class II · Moderate risk Terminated
Losartan Potassium 50 mg Tablet
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk Terminated
Kill 'Dat Sanitizing Products Hand Sanitizer
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Class II · Moderate risk Terminated
Sermorelin Acetate 1 mg/mL
Reason 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 Terminated
Pt-141
Reason 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 Terminated
Melanotan II 1 mg/mL
Reason 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 Terminated
LL-37 2 mg/mL
Reason 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 Terminated
Ipamorelin Acetate/Sermorelin Acetate
Reason 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 Terminated
BPC-157 2 mg/mL
Reason 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 Terminated
Ara-290
Reason 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 Terminated
BEAK & SKIFF SANITIZER Alcohol Antiseptic 80%
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Class II · Moderate risk Terminated
HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80%…
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Terminated
NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution
Reason Failed Reconstitution time
Class II · Moderate risk Terminated
Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial
Reason 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 Terminated
Hydroxocobalamin B12
Reason 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 Terminated
Ultratest
Reason 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 Terminated
Testosterone Cypionate 200 mg/mL
Reason 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 Terminated
Testosterone Cypionate 200 mg/mL
Reason 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 Terminated
Phenylephrine 1 mg/mL
Reason 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 Terminated
Formula F2
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated