Class II · Moderate risk
All Sterile Products manufactured by NECC
Lack of Assurance of Sterility
FDA Drug Recalls
6,161 recalls · Class II, newest first
Class II · Moderate risk
Cyanocobalamin Injection
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class II · Moderate risk
Ondansetron Injection
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class II · Moderate risk
Midazolam Hydrochloride Injection
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class II · Moderate risk
Triamcinolone 10 mg/mL P
Lack of Assurance of Sterility
Class II · Moderate risk
Saline 10% and 3%
Lack of Assurance of Sterility
Class II · Moderate risk
Omnipaque 240mg/mL PF
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine 1% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine/Dextrose 5%/7.5% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Isovue 200 mg/mL PF and 300 mg/mL PF
Lack of Assurance of Sterility
Class II · Moderate risk
Hyaluronidase 150 u/ml PF
Lack of Assurance of Sterility
Class II · Moderate risk
Glycerin 100% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone Sodium Phosphate 4 mg/mL vials PF
Lack of Assurance of Sterility
Class II · Moderate risk
Clonidine 100 mcg/mL PF
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine 0.25% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Sodium Phosphate 6 mg/mL P Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Repository 6 mg/mL PF Injection and Betamethasone…
Lack of Assurance of Sterility
Class II · Moderate risk
Cymevene 500 mg Powder for Infusion
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Class II · Moderate risk
Diazepam Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Preservative-Free MORPHINE Sulfate Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Class II · Moderate risk
I-C Drops
Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.
Class II · Moderate risk
CMS-2374-R4 Custom US Breast Core Biopsy Tray
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Class II · Moderate risk
CMS-8934 Custom Phlebectomy Tray
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Class II · Moderate risk
Custom Access Tray
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags
Class II · Moderate risk
Indocyanine Green - Kit 15mg Injectable 1 Kit
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.