CGMP Deviations:Noted during FDA inspection
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Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company…
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Read MoreTADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, “For Prescription Compounding Only”, Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox,…
CGMP Deviations:Noted during FDA inspection
Read MoreCLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC…
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Read MoreSEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102,…
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Read MoreSEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO…
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Read MoreSEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO…
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Read MoreCLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a…
Lack of assurance of sterility. The recall is due to potential contamination
Read MoreSEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste…
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Read MoreEarly Alert: Convenience Kit Issue from Becton Dickinson
BD is correcting convenience kits and procedural trays containing recalled Huons Co. sodium chloride ampules
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