Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW…
Reason 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 Terminated
Venlafaxine Hydrochloride
Reason Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
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 II · Moderate risk Ongoing
Amoxicillin and Clavulanate Potassium Tablets USP
Reason Subpotent Drug
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 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 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.
Class II · Moderate risk Ongoing
suntegrity
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Dexamethasone Sodium Phosphate injection USP
Reason Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Class II · Moderate risk Ongoing
Zoledronic Acid Injection 5mg/100mL Sterile Solution
Reason Lack of Assurance of Sterility: Leaking vials
Class II · Moderate risk Ongoing
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Class II · Moderate risk Ongoing
Extra Strength Acetaminophen 500 MG Tablets
Reason Discoloration: Brownish tablets
Class II · Moderate risk Ongoing
Labetalol Hydrochloride Injection
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk Ongoing
Buprenorphine Hydrochloride Injection
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk Terminated
Cathflo activase
Reason Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.