Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222; NDC 52533-103-13
Cantrell Drug Company
Lack of Sterility Assurance.
💊 Drugs • 12,141 recalls
Cantrell Drug Company
Lack of Sterility Assurance.
Presence of Particulate Matter: Silicone oil
Lack of Sterility Assurance.
Cantrell Drug Company
Lack of Sterility Assurance.
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.
Bayer HealthCare Pharmaceuticals
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Hospira a Pfizer Company
Lack of Sterility Assurance
Bayer HealthCare Pharmaceuticals
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Hospira a Pfizer Company
Lack of Sterility Assurance
PD-Rx Pharmaceuticals
Failed Tablet/Capsule Specification: out of specification for tablet weight.
Bayer HealthCare Pharmaceuticals
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Failed Dissolution Specifications
Hospira a Pfizer Company
Lack of Sterility Assurance
Zydus Pharmaceuticals USA
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Fusion IV Pharmaceuticals, Inc.
CGMP Deviations
Failed Dissolution Specifications