Class I - Dangerous
Product Mix-up: Incorrect diluent component included in the kit.
💊
Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Class I - Dangerous
Labeling: Incorrect Instructions
ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1
IntegraDose Compounding Services
Class I - Dangerous
Lack of sterility assurance.
Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213
New Vitalis Pharmacy LLC
Class I - Dangerous
Lack of Assurance of Sterility
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class I - Dangerous
Defective container: Cracked vials leading to lack of sterility assurance
Cedar Fever Drops, 20% USP ALCOHOL, 30 mL, homeopathic drug for symptoms of cder allerges, Manufactured for Peoples RX, 3801 S Lamar, Austin, TX 78704. UPC 7 40640 64166 8
Washington Homeopathic Products
Class I - Dangerous
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1
IntegraDose Compounding Services
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42
American Health Packaging
Class I - Dangerous
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class I - Dangerous
Finished product specification did not meet USP specifications.
Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.
Jacobus Pharmaceutical Company
Class I - Dangerous
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Class I - Dangerous
Failed Dissolution Specifications