Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
D-0131-2024November 29, 2023Dublin, OH
Cardinal Health Inc.
Class IOngoing
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70...
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
D-0134-2024November 29, 2023Dublin, OH
Cardinal Health Inc.
Class IOngoing
LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 7...
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
D-0135-2024November 29, 2023Dublin, OH
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Class ITerminated
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
D-0107-2024November 29, 2023La Vergne, TN
Cardinal Health Inc.
Class IOngoing
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
D-0133-2024November 29, 2023Dublin, OH
Cardinal Health Inc.
Class IOngoing
LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
D-0132-2024November 29, 2023Dublin, OH
Cardinal Health Inc.
Class IOngoing
LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
D-0136-2024November 29, 2023Dublin, OH
Pine Pharmaceuticals, LLC
Class IITerminated
Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0062-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0058-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 141...
Reason: Lack of Assurance of Sterility
D-0056-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0052-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0063-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0061-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0051-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0059-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0053-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0055-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0054-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0060-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0057-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0064-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0050-2024October 25, 2023Tonawanda, NY
Pine Pharmaceuticals, LLC
Class IITerminated
Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason: Lack of Assurance of Sterility
D-0065-2024October 25, 2023Tonawanda, NY
Central Admixture Pharmacy Services Inc
Class IITerminated
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1