Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
Reason: Lack of Assurance of Sterility
D-0651-2024September 11, 2024Exton, PA
Fagron Compounding Services
Class IIOngoing
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.
Reason: Lack of Assurance of Sterility
D-0636-2024August 28, 2024Wichita, KS
EMPOWER CLINIC SERVICES LLC
Class IITerminated
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX...
Reason: Lack of Assurance of Sterility
D-0630-2024August 14, 2024Houston, TX
Baxter Healthcare Corporation
Class IIOngoing
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 U...
Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
D-0587-2024July 17, 2024Deerfield, IL
Pfizer Inc.
Class IIOngoing
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., ...
Reason: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
D-0565-2024July 3, 2024New York, NY
Pfizer Inc.
Class IIOngoing
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., L...
Reason: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
D-0564-2024July 3, 2024New York, NY
Imprimis NJOF, LLC
Class IIOngoing
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 4...
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
Reason: Lack of Assurance of Sterility
D-0515-2024June 5, 2024Ledgewood, NJ
Imprimis NJOF, LLC
Class IIOngoing
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Le...
Reason: Lack of Assurance of Sterility
D-0514-2024June 5, 2024Ledgewood, NJ
Genentech, Inc.
Class IITerminated
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Reason: Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
D-0509-2024June 5, 2024South San Francisco, CA
Imprimis NJOF, LLC
Class IIOngoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640...
Reason: Lack of Assurance of Sterility
D-0512-2024June 5, 2024Ledgewood, NJ
Imprimis NJOF, LLC
Class IIOngoing
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71...
Reason: Lack of Assurance of Sterility
D-0513-2024June 5, 2024Ledgewood, NJ
Imprimis NJOF, LLC
Class IIOngoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-...
Reason: Lack of Assurance of Sterility
D-0519-2024June 5, 2024Ledgewood, NJ
Regeneron Pharmaceuticals Inc
Class IITerminated
EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Ol...
Reason: Lack of Assurance of Sterility: Complaints of syringe breakage
D-0531-2024June 5, 2024Tarrytown, NY
Imprimis NJOF, LLC
Class IIOngoing
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
Reason: Lack of Assurance of Sterility
D-0516-2024June 5, 2024Ledgewood, NJ
Dr. Reddy's Laboratories, Inc.
Class IIOngoing
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52
Reason: Lack of Assurance of Sterility: Leaking vials
D-0510-2024June 5, 2024Princeton, NJ
American Regent, Inc.
Class IITerminated
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc....
Reason: Lack of Assurance of Sterility.
D-0503-2024May 29, 2024New Albany, OH
Regeneron Pharmaceuticals Inc
Class IITerminated
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, ...
Reason: Lack of Assurance of Sterility: Complaints of syringe breakage
D-0479-2024May 8, 2024Tarrytown, NY
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Class IIOngoing
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, ...
Reason: Lack of Assurance of Sterility: Firm did not perform process validation.
D-0436-2024April 10, 2024Fenton, MO
IntegraDose Compounding Services LLC
Class IIOngoing
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
Reason: Lack of Assurance of Sterility: leaking bags