Class II · Moderate risk
Testosterone Cypionate Injection
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
FDA Drug Recalls
1,206 recalls · Class II, newest first
Class II · Moderate risk
Clonazepam Orally Disintegrating Tablets
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Class II · Moderate risk
Testosterone Cypionate Injection
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Class II · Moderate risk
Artri King Reforzado con Ortiga Omega 3 Tablets
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Class II · Moderate risk
Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Class II · Moderate risk
Earache Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
Homeopathic EarAche Ear Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
Homeopathic EarAche Drops
Microbial contamination of non-sterile product.
Class II · Moderate risk
B-Complex + Chromic Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Ethanol for Injection 95%
Lack of Assurance of Sterility
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Succinylcholine Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Rocuronium Bromide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Oxytocin 30 Units/500 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Neostigmine Methylsulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Labetalol HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine Hydrochloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine Hydrochloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl Injection
Lack of Assurance of Sterility