💊 Drugs • 11,927 recalls
Dr. Reddy's Laboratories
Failed Impurities/Degradation Specifications: Related Substances
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
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
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Discoloration: Brownish tablets
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Coast Quality Pharmacy, LLC
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Failed Content Uniformity Specifications
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Breckenridge Pharmaceutical
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Subpotent Drug
Lack of Assurance of Sterility
Winder Laboratories
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Sagent Pharmaceuticals
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Defective Container
Sagent Pharmaceuticals
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.