Class II · Moderate risk Terminated
AscorbiX
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil/Papaverine Hydrochloride/Phentolamine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil/Papaverine Hydrochloride/Phentolamine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Alprostadil/Papaverine Hydrochloride/Phentolamine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ranitidine 300 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Ranitidine 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Ranitidine Hydrochloride
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Nystatin Oral Suspension
Reason Subpotent: Out of specification for assay at the 12-month time point.
Class II · Moderate risk Terminated
Testosterone Cypionate for Injection
Reason cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Class II · Moderate risk Terminated
Testosterone Cypionate for Injection
Reason cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Class II · Moderate risk Terminated
ranitidine hydrochloride
Reason CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class II · Moderate risk Terminated
Netspot
Reason Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Class II · Moderate risk Terminated
Estriol USP Micronized a) 100 gm NDC 62991-2159-04
Reason Subpotent
Class II · Moderate risk Terminated
Preferred Pharmaceuticals
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Preferred Pharmaceuticals
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Nizatidine Capsules
Reason CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class II · Moderate risk Terminated
Nizatidine Capsules
Reason CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class II · Moderate risk Terminated
Dutasteride Capsules
Reason Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Class II · Moderate risk Terminated
Ranitidine Capsules 150 mg
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
Ranitidine Capsules 300 mg
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
Ranitidine
Reason CGMP Deviations: Presence of NDMA impurity detected in product.