Class II · Moderate risk
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection
Lack of Assurance of Sterility
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Ranitidine 300 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Hydrochloride
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Nystatin Oral Suspension
Subpotent: Out of specification for assay at the 12-month time point.
Class II · Moderate risk
Testosterone Cypionate for Injection
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Class II · Moderate risk
Testosterone Cypionate for Injection
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Class II · Moderate risk
ranitidine hydrochloride
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class II · Moderate risk
Netspot
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Class II · Moderate risk
Class II · Moderate risk
Preferred Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Preferred Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Nizatidine Capsules
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class II · Moderate risk
Nizatidine Capsules
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class II · Moderate risk
Dutasteride Capsules
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Class II · Moderate risk
Ranitidine Capsules 150 mg
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Capsules 300 mg
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Sumatriptan Succinate Tablets
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II · Moderate risk
Sumatriptan Succinate Tablets
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II · Moderate risk
Ranitidine 150 mg tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine 150 mg tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Blisovi Fe 1.5/30
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Class II · Moderate risk
Theraflu Cough Relief
Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.