Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Clonazepam Orally Disintegrating Tablets
Reason Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason 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 I · High risk Terminated
Artri King Reforzado con Ortiga y Omega 3 tablets
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Class I · High risk Terminated
Ortiga mas Ajo Rey Reforzado con Omega 3
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Class I · High risk Terminated
Artri Ajo King Reforzado con Ortiga y Omega 3 tablets
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Class II · Moderate risk Terminated
Earache Drops
Reason Microbial contamination of non-sterile product.
Class II · Moderate risk Terminated
Homeopathic EarAche Ear Drops
Reason Microbial contamination of non-sterile product.
Class II · Moderate risk Terminated
Homeopathic EarAche Drops
Reason Microbial contamination of non-sterile product.
Class II · Moderate risk Terminated
B-Complex + Chromic Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ethanol for Injection 95%
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
Tegsedi
Reason Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Class III · Low risk Terminated
Alprostadil Injection USP 500 mcg/mL
Reason Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Succinylcholine Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Rocuronium Bromide Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Oxytocin 30 Units/500 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Neostigmine Methylsulfate Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine HCl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Labetalol HCl Injection
Reason Lack of Assurance of Sterility