Labeling: Missing Label: label missing from some Semglee prefilled pens.
Drugs Recalls
Prescription and over-the-counter medications
Failed Dissolution Specifications
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
Ingenus Pharmaceuticals
CGMP Deviations
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3
Dr. Reddy's Laboratories
Subpotent drug
Failed Dissolution Specifications
Failed Dissolution Specifications
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Microbial Contamination of Non-Sterile Product
Failed Dissolution Specifications
Failed Stability Specifications
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Exela Pharma Sciences
Lack of Assurance of Sterility
Defective Delivery System
Labeling: Missing Label
Labeling: Missing Label