Class II · Moderate risk Ongoing
Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Hydrocortisone and Acetic Acid Otic Solution
Reason Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Class II · Moderate risk Ongoing
Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10…
Reason CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class II · Moderate risk Terminated
Estriol
Reason Subpotent Drug: Supplier indicated assay results did not meet specifications.
Class II · Moderate risk Terminated
Estriol
Reason Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class II · Moderate risk Terminated
Estriol
Reason Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class II · Moderate risk Terminated
Estriol
Reason Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class II · Moderate risk Terminated
Raloxifene Hydrochloride Tablets
Reason Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Class II · Moderate risk Terminated
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Amantadine Hydrochloride Tablets
Reason Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Class II · Moderate risk Terminated
25% Dextrose Injection
Reason Labeling: Incorrect or Missing Lot and/or expiration date.
Class II · Moderate risk Terminated
Lidocaine HCl 2% 5 mL
Reason Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
Class II · Moderate risk Terminated
Petroleum jelly
Reason Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.
Class II · Moderate risk Terminated
Estriol
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Vancomycin Hydrochloride for Injection
Reason Discoloration: Product complaints of discoloration after reconstitution of vials.
Class II · Moderate risk Ongoing
Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Ongoing
Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Ongoing
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz.
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Ongoing
Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Ongoing
Ranitidine Tablets
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
Exparel
Reason Sub Potent Drug: Out of Specification (OOS)
Class II · Moderate risk Terminated
Ibuprofen Oral Suspension USP
Reason Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Ranitidine Tablets
Reason CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Class II · Moderate risk Terminated
Gabapentin Capsules
Reason Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..