Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination
D-0357-2025April 16, 2025Bengaluru, N/A
QuVa Pharma, Inc.
Class IIOngoing
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Instit...
Reason: Lack of Assurance of Sterility
D-0295-2025April 2, 2025Sugar Land, TX
Exela Pharma Sciences LLC
Class IIOngoing
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 286...
Reason: Lack of Assurance of Sterility
D-0303-2025April 2, 2025Lenoir, NC
QuVa Pharma, Inc.
Class IIOngoing
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For I...
Reason: Lack of Assurance of Sterility
D-0296-2025April 2, 2025Sugar Land, TX
QuVa Pharma, Inc.
Class IIOngoing
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Instit...
Reason: Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
D-0259-2025March 19, 2025El Paso, TX
Wuxi Medical lnstrument Factory Co., Ltd.
Class IIOngoing
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in C...
Reason: Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
D-0247-2025March 5, 2025Wuxi, N/A
Turbare Manufacturing
Class IICompleted
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Driv...
Reason: Lack of Assurance of Sterility: due to a quality control process deviation
D-0248-2025March 5, 2025Conway, AR
Fagron Compounding Services
Class IICompleted
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
D-0174-2025January 8, 2025Dayton, NJ
Hikma Injectables USA Inc
Class IITerminated
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office ...
Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
D-0173-2025January 8, 2025Dayton, NJ
Curium US, LLC
Class IITerminated
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tet...
Reason: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1
Reason: Lack of Sterility Assurance
D-0051-2025November 27, 2024Phoenix, AZ
AbbVie Inc.
Class IIOngoing
Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 3002303...
Reason: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
D-0665-2024October 2, 2024North Chicago, IL
AbbVie Inc.
Class IIOngoing
Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
Reason: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
D-0664-2024October 2, 2024North Chicago, IL
Empower Pharmacy
Class IITerminated
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041...