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.
Ongoing drug recalls - open right now
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
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
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 III · Low risk
Eszopiclone Tablets
Failed Impurities/Degradation Specifications: Related Substances
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium Tablets USP
Subpotent Drug
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 I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class III · Low risk
Asmanex Twisthaler
Defective Container
Class II · Moderate risk
suntegrity
CGMP Deviations
Class I · High risk
suntegrity
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Class II · Moderate risk
Dexamethasone Sodium Phosphate injection USP
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Class II · Moderate risk
Zoledronic Acid Injection 5mg/100mL Sterile Solution
Lack of Assurance of Sterility: Leaking vials
Class II · Moderate risk
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Class III · Low risk
Eptifibatide injection 20mg/10mL
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Class II · Moderate risk
Extra Strength Acetaminophen 500 MG Tablets
Discoloration: Brownish tablets
Class II · Moderate risk
Labetalol Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk
Buprenorphine Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class III · Low risk
Estradiol Transdermal System
Failed Impurities/Degradation Specifications.