Prescription and over-the-counter medications
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
Teva Pharmaceuticals USA
Failed Tablet/Capsule Specification; out of specification for tablet weight
Hospira a Pfizer Company
Lack of Sterility Assurance
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
SCA Pharmaceuticals
Lack of Assurance of Sterility; product has the potential to leak.
SCA Pharmaceuticals
Lack of Assurance of Sterility; product has the potential to leak.
SCA Pharmaceuticals
Lack of Assurance of Sterility; product has the potential to leak.
SCA Pharmaceuticals
Lack of Assurance of Sterility; product has the potential to leak.
SCA Pharmaceuticals
Lack of Assurance of Sterility; product has the potential to leak.
SCA Pharmaceuticals
Lack of Assurance of Sterility; product has the potential to leak.
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.