Class II · Moderate risk
Little Moon Essentials
CGMP deviations
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW…
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Class II · Moderate risk
Venlafaxine Hydrochloride
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Class III · Low risk
Dodex Injectable
Subpotent drug: out of specification results
Class II · Moderate risk
Dianeal Low Calcium
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Class II · Moderate risk
Methylphenidate Hydrochloride
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Class II · Moderate risk
Zilretta (triamcinolone acetonide extended-release injectable suspension)
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
Oatmeal Daily Moisturizing Body Lotion
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Class II · Moderate risk
Allopurinol Tablets
Presence of foreign substance.
Class II · Moderate risk
STELLALIFE ADVANCED FORMULA Peppermint
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Class I · High risk
STELLALIFE VEGA Oral Care
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Class III · Low risk
Eszopiclone Tablets
Failed Impurities/Degradation Specifications: Related Substances
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium Tablets USP
Subpotent Drug
Class III · Low risk
Complete 30C/200C Homeopathic Kit
Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
Class II · Moderate risk
Phenazopyridine HCl
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Class II · Moderate risk
Potassium Chloride Extended-Release Capsules
CGMP Deviations
Class II · Moderate risk
Potassium Chloride Extended-Release Capsules
CGMP Deviations
Class I · High risk
Potassium Chloride Extended-Release Capsules
Failed Dissolution Specifications
Class I · High risk
Potassium Chloride Extended-Release Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Cefixime for Oral Suspension USP 200 mg/5 mL
Failed Content Uniformity Specifications
Class II · Moderate risk
Petroleum Jelly
Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Class II · Moderate risk
Little Remedies Gas Relief Drops
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.