Class III · Low risk Terminated
NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP
Reason Subpotent Drug
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Class III · Low risk Terminated
Memantine Hydrochloride Extended-release Capsules
Reason Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III · Low risk Terminated
Bimatoprost Ophthalmic Solution
Reason Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
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 III · Low risk Terminated
Memantine Hydrochloride Extended-release Capsules
Reason Failed Dissolution Specifications: High out of specification result observed at stability studies.
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 I · High risk Terminated
Levetiracetam Oral Solution 100mg/mL
Reason Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Class II · Moderate risk Terminated
Raloxifene Hydrochloride Tablets
Reason Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Class III · Low risk Terminated
Moxifloxacin Ophthalmic Solution USP
Reason Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
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 III · Low risk Terminated
VCF Vaginal Contraceptive Foam
Reason Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
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