CGMP Deviations: Firm did not adequately investigate customer complaints.
Prescription Drugs
💊 Drugs • 12,141 recalls
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.
Bethel Nutritional Consulting
Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
Failed pH Specifications: 12 month stability testing
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.
Mylan Pharmaceuticals
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11
Teva Pharmaceuticals USA
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.