Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
All Recalls
95,018 total recalls in our database
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
Lack of sterility assurance.
cGMP Deviations
Quebracho 4C, Fever*, 20% Alcohol, Packaged as 100ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
Washington Homeopathic Products
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.
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
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.
cGMP Deviations
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.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Cinnamomum 6X, Flatulence* Sucrose/Lactose Pills, Packaged as a) 4 Dram, b) 1 oz, and Cinnamomum 30X, Flatulence* Sucrose/Lactose Pills, Packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411
Washington Homeopathic Products
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.
Finished product specification did not meet USP specifications.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
Washington Homeopathic Products
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
cGMP Deviations
Althaea 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 1 OZ, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
Washington Homeopathic Products
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Althaea Officinalis 4X, Iritable Bladder* packaged as Sucrose/Lactose Pills, 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
Washington Homeopathic Products
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Althaea 6X, Iritable Bladder* 20% Alcohol, Drops, packaged as 15 ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
Washington Homeopathic Products
Out-of-specification test results obtained for identification testing based on HPTLC analysis.