TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes17 reports about syringe on this site. See them all →, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compoun…

GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12; Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes17 reports about syringe on this site. See them all →, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936, Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide …

ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07; Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes17 reports about syringe on this site. See them all →, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936, Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide w…

BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22. Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class IIIThe lowest FDA recall level: unlikely to cause health problems, but it breaks the rules. · Ongoing · Worldwide - Nationwide and the country of Canada.

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes17 reports about syringe on this site. See them all →, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide wit…

GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03; Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Sterile EYE DROPS18 reports about eye drop on this site. See them all → Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0456-1; b) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25392 6; c) GoodSense, Distributed By: Gei…

Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Version: N/A Reason: An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027. Class IIIThe lowest FDA recall level: unlikely to cause health problems, but it breaks the rules. · Ongoing · U.S.: CA O.U…

Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67. Reason: Failed Impurities/Degradation Specifications Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. …

MAJOR PACK; Model/Item Number (Kit): NIHB0018-11; Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes17 reports about syringe on this site. See them all →, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product…

Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60). Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class IIIThe lowest FDA recall level: unlikely to cause health problems, but it breaks the rules. · Ongoing · Worldwide - Nationwide and the country of Canada.

IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01 Reason: Presence of particulate matter. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · OH

Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMSVM4166A Intubation UH Kit Catalog Number AN2336608G Reason: Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these componen…

Sterile Eye Drops18 reports about eye drop on this site. See them all →, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47011 3; b) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01157 3; c) Good Sense Sterile…

DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252 Reason: Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical …

Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes17 reports about syringe on this site. See them all →, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide w…

SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000; Reason: During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to…

Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18. Reason: Lack of Assurance of Sterility Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the United States

DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16; Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Lidocaine Ointment3 reports about ointment on this site. See them all → USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC): 68788-7865-05 Reason: Failed Content Uniformity Specifications Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · USA Nationwide

BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80 Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions Class IIIThe lowest FDA recall level: unlikely to cause health problems, but it breaks the rules. · Ongoing · Worldwide - Nationwide and the country of Canada.

Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes17 reports about syringe on this site. See them all →, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compou…

ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04; Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.

Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02. Reason: Failed Impurities/Degradation Specifications Class IIIThe lowest FDA recall level: unlikely to cause health problems, but it breaks the rules. · Ongoing · US Nationwide.

HALYARD Laparoscopy Comprehensive Pack II REF: 49332 Reason: Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the state of MS.

TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes17 reports about syringe on this site. See them all →, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936; Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compou…

Alphenix INFX-8000C/B5 Reason: Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide distribution in the state of ID.