Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

6,275 results found for sterility Page 34 of 251
Sentara Infusion Services
Class II Terminated
Ampicillin/Sulbactam 3GM IN NS 100ML, antibiotic, Rx only, used with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Reason: Lack of sterility assurance
D-0276-2023 February 22, 2023 Chesapeake, VA
Sentara Infusion Services
Class II Terminated
TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Reason: Lack of sterility assurance
D-0317-2023 February 22, 2023 Chesapeake, VA
Leadiant Biosciences, Inc.
Class II Terminated
Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 2087...
Reason: Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
D-0327-2023 February 22, 2023 Gaithersburg, MD
Sentara Infusion Services
Class II Terminated
PIPERACILLIN / TAZOBACTAM (a) 4.5GM IN NS 100 ML, (b)18GM IN NS 267M, (c) 27GM IN NS 400ML, (d) 3.375 GM IN NS 50ML, (e) 36 GM IN NS 533 ML, antibiotic, Rx only, use with a Curlin or home pump or no ...
Reason: Lack of sterility assurance
D-0315-2023 February 22, 2023 Chesapeake, VA
Sentara Infusion Services
Class II Terminated
METRONIDAZOLE 500MG 100ML, antibiotic, Rx Only, use with a home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Reason: Lack of sterility assurance
D-0306-2023 February 22, 2023 Chesapeake, VA
Sentara Infusion Services
Class II Terminated
CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Reason: Lack of sterility assurance
D-0280-2023 February 22, 2023 Chesapeake, VA
Sentara Infusion Services
Class II Terminated
Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500ML (NDC 00338-0117-03)hydration, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pk...
Reason: Lack of sterility assurance
D-0300-2023 February 22, 2023 Chesapeake, VA
Sentara Infusion Services
Class II Terminated
Levaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Reason: Lack of sterility assurance
D-0301-2023 February 22, 2023 Chesapeake, VA
Sentara Infusion Services
Class II Terminated
AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Reason: Lack of sterility assurance
D-0275-2023 February 22, 2023 Chesapeake, VA
Sentara Infusion Services
Class II Terminated
HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00009-0011-04
Reason: Lack of sterility assurance
D-0295-2023 February 22, 2023 Chesapeake, VA
Sentara Infusion Services
Class II Terminated
MYCAMINE 100MG IN NS 100ML, antifungal, Rx Only, use with a homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Reason: Lack of sterility assurance
D-0309-2023 February 22, 2023 Chesapeake, VA
Pharmacy Innovations
Class II Terminated
TESTOSTERONE 3% (4GM TUBE) OPHTH OINTME TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/0.5MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERO...
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0238-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclosporine (A) 2%; Cyclosporine (A) - Corn oil - 1% Oph solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0200-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
MITOMYCIN 0.4MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.4MG/ML (1ML VIAL) OPH SOLUTION; MITOMYCIN 0.4MG/ML (4ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0224-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0190-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
Ceftazidime Intravitreal (1ML vial) 22.5 MG/ML(2.25MG/0.1ML) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0197-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25...
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0209-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0189-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
MITOMYCIN 0.2MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.2MG/ML (1ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0223-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION TACROLIMUS-VET- 0.02% (10ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (15ML DROPP...
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0237-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
FLURBIPROFEN -CORN OIL- 0.04% (3ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0208-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
EDETATE DISODIUM (VET) 1% (3ML droptainer) OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0204-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE- 50,000IU/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0242-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0212-2023 February 1, 2023 Erie, PA
Pharmacy Innovations
Class II Terminated
POLIDOCANOL 50MG/ML (5%) (30ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
D-0231-2023 February 1, 2023 Erie, PA