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.
FDA Drug Recalls
2,661 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 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 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 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 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 Ongoing
suntegrity
Reason CGMP Deviations
Class I · High risk Ongoing
suntegrity
Reason Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
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 III · Low risk Ongoing
Eptifibatide injection 20mg/10mL
Reason Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
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 III · Low risk Ongoing
Estradiol Transdermal System
Reason Failed Impurities/Degradation Specifications.