Class II · Moderate risk Terminated
Magnesium Citrate SALINE LAXATIVE
Reason CGMP Deviations
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Common Sense Fragrance Free Hand Sanitizer
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Protect U Guard Foaming Hand Sanitizer
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Protect U Guard Foaming Hand Sanitizer Ophardt
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Stage 2-Ophardt Foaming Hand Sanitizer
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Avant Foaming Hand Sanitizer Ophardt
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Avant Foaming Hand Sanitizer
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Fulvestrant Injection 250mg/5mL
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Difluprednate Ophthalmic Emulsion
Reason Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Reason FAILED DISSOLUTION SPECIFICATIONS
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Reason FAILED DISSOLUTION SPECIFICATIONS
Class II · Moderate risk Terminated
Lorazepam Injection
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II · Moderate risk Terminated
Lorazepam Injection
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II · Moderate risk Terminated
Ativan Injection
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II · Moderate risk Terminated
Lorazepam Injection
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II · Moderate risk Terminated
Naftifine Hydrochloride Gel
Reason Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Class II · Moderate risk Terminated
Succinylcholine Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Anticoagulant Sodium Citrate Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ropivacaine HCl 123 mg
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