Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
Class II · Moderate risk Ongoing
Little Moon Essentials
Reason CGMP deviations
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 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 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 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 Ongoing
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Klarity-C
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use…
Reason Lack of Assurance of Sterility