Class III · Low risk Terminated
Dodex Injectable
Reason Subpotent drug: out of specification results
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Dianeal Low Calcium
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Class II · Moderate risk Terminated
Methylphenidate Hydrochloride
Reason Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Class II · Moderate risk Ongoing
Zilretta
Reason Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Class II · Moderate risk Ongoing
Oatmeal Daily Moisturizing Body Lotion
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Class II · Moderate risk Terminated
Allopurinol Tablets
Reason Presence of foreign substance.
Class II · Moderate risk Terminated
STELLALIFE ADVANCED FORMULA Peppermint
Reason Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Class I · High risk Terminated
STELLALIFE VEGA Oral Care
Reason Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Class III · Low risk Ongoing
Eszopiclone Tablets
Reason Failed Impurities/Degradation Specifications: Related Substances
Class II · Moderate risk Ongoing
Amoxicillin and Clavulanate Potassium Tablets USP
Reason Subpotent Drug
Class III · Low risk Terminated
Complete 30C/200C Homeopathic Kit
Reason Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
Class II · Moderate risk Terminated
Phenazopyridine HCl
Reason Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Class II · Moderate risk Ongoing
Potassium Chloride Extended-Release Capsules
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Potassium Chloride Extended-Release Capsules
Reason CGMP Deviations
Class I · High risk Ongoing
Potassium Chloride Extended-Release Capsules
Reason Failed Dissolution Specifications
Class I · High risk Ongoing
Potassium Chloride Extended-Release Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Cefixime for Oral Suspension USP 200 mg/5 mL
Reason Failed Content Uniformity Specifications
Class II · Moderate risk Terminated
Petroleum Jelly
Reason Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Class II · Moderate risk Terminated
Little Remedies Gas Relief Drops
Reason cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Class I · High risk Ongoing
Docetaxel Injection
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I · High risk Ongoing
Docetaxel Injection
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class III · Low risk Ongoing
Asmanex Twisthaler
Reason Defective Container
Class III · Low risk Ongoing
Asmanex Twisthaler
Reason Defective Container
Class III · Low risk Ongoing
Asmanex Twisthaler
Reason Defective Container
Class II · Moderate risk Completed
Phenazopyridine HCl Tablets USP
Reason Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.