Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 49 of 251
Edge Pharma, LLC
Class II Terminated
Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05...
Reason: Lack of Assurance of Sterility
D-0404-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01
Reason: Lack of Assurance of Sterility
D-0396-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446...
Reason: Lack of Assurance of Sterility
D-0403-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 0544...
Reason: Lack of Assurance of Sterility
D-0418-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03
Reason: Lack of Assurance of Sterility
D-0394-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 He...
Reason: Lack of Assurance of Sterility
D-0414-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colcheste...
Reason: Lack of Assurance of Sterility
D-0427-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose: 1.25mg/0.05mL, Single Use Syringe For Intraocular Injection, Edge Pharma, LLC,...
Reason: Lack of Assurance of Sterility
D-0412-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT ...
Reason: Lack of Assurance of Sterility
D-0425-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05
Reason: Lack of Assurance of Sterility
D-0411-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr, C...
Reason: Lack of Assurance of Sterility
D-0419-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma LLC, 856 Hercules Dr. Colchester, ...
Reason: Lack of Assurance of Sterility
D-0408-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, ...
Reason: Lack of Assurance of Sterility
D-0422-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT ...
Reason: Lack of Assurance of Sterility
D-0398-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446...
Reason: Lack of Assurance of Sterility
D-0401-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials...
Reason: Lack of Assurance of Sterility
D-0413-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
Reason: Lack of Assurance of Sterility
D-0407-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT ...
Reason: Lack of Assurance of Sterility
D-0426-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LL, 856 Hercules Dr.,...
Reason: Lack of Assurance of Sterility
D-0410-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules ...
Reason: Lack of Assurance of Sterility
D-0399-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules ...
Reason: Lack of Assurance of Sterility
D-0402-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colcheste...
Reason: Lack of Assurance of Sterility
D-0409-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Colchester, VT 05446, NDC 05446-0815-...
Reason: Lack of Assurance of Sterility
D-0420-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
Reason: Lack of Assurance of Sterility
D-0421-2022 February 2, 2022 Colchester, VT
Edge Pharma, LLC
Class II Terminated
Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01
Reason: Lack of Assurance of Sterility
D-0417-2022 February 2, 2022 Colchester, VT