urlscan.io logo urlscan.io
SecurityTrails logo

www.fda.gov Open in urlscan Pro
2a02:26f0:6c00:280::2e60  Public Scan

Back to summary
URL: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/edge-pharma-llc-issues-voluntary-nationwide-reca...
Submission: On June 08 via api from US — Scanned from DE

Form analysis 1 forms found in the DOM

Name: searchForm — GET https://search.usa.gov/search

<form class="fda-masthead__search sr-only" role="search" action="https://search.usa.gov/search" method="GET" name="searchForm" id="search-form" accept-charset="UTF-8">
  <div class="search-popover" id="search-popover">
    <div class="input-group pull-right" id="search-group">
      <label class="sr-only" for="search-query">Search FDA</label>
      <input accesskey="4" class="form-control search-input" id="search-query" name="query" aria-autocomplete="list" aria-haspopup="true" title="Enter the terms you wish to search for." placeholder="Search FDA" type="text">
      <span class="input-group-btn" id="input-group-btn">
        <button type="submit" class="btn btn-danger search-btn" id="search-btn" title="Search"><span class="fa fa-search" aria-hidden="true"><span class="sr-only">Submit search</span></span></button>
      </span>
    </div>
  </div>
  <input name="affiliate" value="fda1" type="hidden">
</form>

Text Content

 * Skip to main content
 * Skip to FDA Search
 * Skip to in this section menu
 * Skip to footer links

An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive
information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that
any information you provide is encrypted and transmitted securely.


U.S. FOOD AND DRUG ADMINISTRATION

 *   Search
 *   Menu

Search FDA Submit search


FEATURED

 * Contact FDA
 * FDA Guidance Documents
 * Recalls, Market Withdrawals and Safety Alerts
 * Press Announcements
 * Warning Letters
 * Advisory Committees
 * En Español


PRODUCTS

 * Food
 * Drugs
 * Medical Devices
 * Radiation-Emitting Products
 * Vaccines, Blood, and Biologics
 * Animal and Veterinary
 * Cosmetics
 * Tobacco Products


TOPICS

 * About FDA
 * Combination Products
 * Regulatory Information
 * Safety
 * Emergency Preparedness
 * International Programs
 * News and Events
 * Training and Continuing Education
 * Inspections and Compliance
 * Science and Research


INFORMATION FOR

 * Consumers
 * Patients
 * Industry
 * Health Professionals
 * Federal, State and Local Officials


In this section: Recalls, Market Withdrawals, & Safety Alerts
 * Recalls, Market Withdrawals, & Safety Alerts
    * Recall Resources
   
    * Enforcement Reports
    * Industry Guidance For Recalls
    * Major Product Recalls
    * Archive for Recalls, Market Withdrawals & Safety Alerts

 1. Home
 2. Safety
 3. Recalls, Market Withdrawals, & Safety Alerts
 4. Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due
    to Lack of Sterility Assurance

 1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT


EDGE PHARMA, LLC ISSUES VOLUNTARY NATIONWIDE RECALL OF ALL DRUG PRODUCTS DUE TO
LACK OF STERILITY ASSURANCE

When a company announces a recall, market withdrawal, or safety alert, the FDA
posts the company's announcement as a public service. FDA does not endorse
either the product or the company.

Read Announcement
 * Share
 * Tweet
 * Linkedin
 * Email
 * Print




SUMMARY

Company Announcement Date: December 04, 2021 FDA Publish Date: December 07, 2021
Product Type: Drugs Reason for Announcement:
Recall Reason Description
Process issues that could lead to a lack of sterility assurance for products
intended to be sterile and could impact the safety and quality of non-sterile
products
Company Name: Edge Pharma, LLC Brand Name:
Brand Name(s)
Edge Pharma, LLC
Product Description:
Product Description
All drugs compounded at Edge Pharma, LLC

--------------------------------------------------------------------------------


COMPANY ANNOUNCEMENT

FOR IMMEDIATE RELEASE – December 4, 2021 – Colchester, VT, Edge Pharma, LLC is
voluntarily recalling all lots of all drugs compounded at Edge Pharma, LLC to
the consumer level. All products are being recalled due to process issues that
could lead to a lack of sterility assurance for products intended to be sterile
and could impact the safety and quality of non-sterile products.

Risk Statement: Administration of a drug product intended to be sterile, that is
not sterile, could result in site specific infections as well as serious
systemic infections which may be life- threatening. To date, Edge Pharma, LLC
has not received and is not aware of any adverse events related to this recall.

The products are used for a variety of indications and are packaged in
Containers, IV bags, Syringes, Drop containers, Vials, Bottles, and Jars. The
affected lots and expiration dates are included in the link listed below. The
names and concentration of the drugs are listed in the table following this
release.

LINK TO LOT NUMBERS, DISTRIBUTION DATES & DRUG INFORMATION WILL BE ACTIVE ON
12-08-21.

https://edgepharma.com/assets/recalledproducts.pdfExternal Link Disclaimer

The recall encompasses all compounded sterile and nonsterile drug products,
within expiry, that were dispensed from Edge Pharma, LLC. The products subject
to this recall were distributed nationwide and directly to customers and/or
medical facilities. The products can be identified by the label containing the
Edge Pharma, LLC name and logo.

Edge Pharma, LLC is notifying its customers by email, Media and FDA alerts, and
direct outreach. Consumers and institutions that have Edge Pharma, LLC products
should stop using the products immediately and may either return or discard the
recalled lots.

Consumers with questions regarding this recall can contact Edge Pharma, LLC by
phone number or e-mail address on Monday-Friday from 8:00 am to 4:00 pm, EST.
Consumers should contact their physician or healthcare provider if they have
experienced any problems that may be related to taking or using these drug
products.

Adverse reactions or quality problems experienced with the use of this product
may be reported to the FDA's MedWatch Adverse Event Reporting program either
online, by regular mail or by fax.

 * Complete and submit the report Online
 * Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a
   reporting form, then complete and return to the address on the pre-addressed
   form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug
Administration.

STERILE PRODUCTS NDC ALUMINUM POTASSIUM SULFATE CONCENTRATED (PF) 300 G/300 ML
05446-0637-03 BUFFERED LIDOCAINE HCL (PF) 1% 05446-0850-10 BUFFERED LIDOCAINE
HCL / EPINEPHRINE SOLUTION (PF) 1% / 1:100,000 05446-1268-01 CEFTAZIDIME (PF)
22.5 MG/ML 05446-0733-01 CEFUROXIME OPHTHALMIC SOLUTION (PF) 10 MG/ML
05446-1003-01 DEXAMETHASONE PHOSPHATE (PF) 24 MG/ML 05446-0848-01 EDETATE
DISODIUM (EDTA) (PF) 1.5% 05446-1427-10 EDETATE DISODIUM (EDTA) (PF) 3%
05446-1428-10 EPINEPHRINE / LIDOCAINE HCL (PF) 0.025% / 0.75% 05446-0863-01
GEMCITABINE (PF) 20 MG/ML 05446-1566-50 GLYCERIN, STERILE (PF) 99% 05446-1486-03
LIDOCAINE HCL / BUPIVACAINE HCL / HYALURONIDASE (PF) 2% / 0.375% / 15 UNITS/ML
05446-1548-18 METHACHOLINE CHALLENGE 5 SYRINGE TEST KIT 05446-1600-05
METHACHOLINE CHLORIDE (PF) 16 MG/ML 05446-1241-01 METHACHOLINE CHLORIDE (PF) 4
MG/ML 05446-1246-01 METHACHOLINE CHLORIDE (PF) 1 MG/ML 05446-1247-01
METHACHOLINE CHLORIDE (PF) 0.25 MG/ML 05446-1248-01 METHACHOLINE CHLORIDE (PF)
0.0625 MG/ML 05446-1249-01 METHOTREXATE (PF) 125 MG/5ML 05446-1505-05 MITOMYCIN
IRRIGATION (PF) 1 MG/ML 05446-1416-01 MITOMYCIN-C (PF) 0.4 MG/ML 05446-1009-01
MITOMYCIN-C (PF) 0.2 MG/ML 05446-1011-01 MOXIFLOXACIN HCL (PF) 1 MG/ML
05446-1050-01 MVASI 3.75MG/0.15ML (25 MG/ML) 05446-1661-13 NEOSTIGMINE
METHYLSULFATE 1 MG/ML 05446-1549-05 NOREPINEPHRINE BITARTRATE 8 MG/250ML
05446-1179-03 PHENOL, STERILE (PF) 6% 05446-1476-05 PHENYLEPHRINE / TROPICAMIDE
/ KETOROLAC / CIPROFLOXACIN (PF) 10% / 1% / 0.125% / 0.3% 05446-1270-01
PHENYLEPHRINE HCL 0.1 MG/ML 05446-1544-10 PHENYLEPHRINE HCL 0.1 MG/ML
05446-1545-05 PHENYLEPHRINE HCL (PF) 800 MCG/10 ML 05446-1652-01 PHENYLEPHRINE
HCL (PF) 20 MG/ 250 ML 05446-1667-01 PHENYLEPHRINE HCL / LIDOCAINE HCL (PF) 1.5%
/ 1% 05446-1118-01 PHENYLEPHRINE HCL / TROPICAMIDE 2.5% / 1% 05446-0815-01
PHENYLEPHRINE/ CYCLOPENTOLATE / TROPICAMIDE / KETOROLAC 10% / 0.25% / 0.25% /
0.125% 05446-0859-03 PHENYLEPHRINE/ CYCLOPENTOLATE / TROPICAMIDE / KETOROLAC
(PF) 2.5% / 0.25% / 0.25% / 0.125% 05446-0993-01 POVIDONE-IODINE (PF) 5%
05446-1680-01 TRYPAN BLUE (PF) 0.03% 05446-1200-01 VANCOMYCIN HCL (PF) 10 MG/ML
05446-0736-01 VANCOMYCIN HCL (PF) 1250 MG/250ML 05446-1456-01 VANCOMYCIN HCL
(PF) 1500 MG/512ML 05446-1458-01 VANCOMYCIN HCL (PF) 1750 MG/514ML 05446-1459-01

STERILE PRODUCTS NDC PRESCRIPTION ALLERGY TREATMENT SETS DISTRIBUTED BETWEEN
12-02-20 to 12-01-21 N/A

NON-STERILE PRODUCTS NDC BENZOCAINE / LIDOCAINE / TETRACAINE 20% / 8% / 4%
05446-1235-01 CANTHARIDIN 0.7% 05446-0572-03 CANTHARIDIN PLUS 1% / 30%
05446-0970-03 CIPROFLOXACIN / SULFACETAMIDE SODIUM / AMPHOTERICIN B 30MG / 50MG
/ 5MG 05446-1633-01 CIPROFLOXACIN / SULFACETAMIDE SODIUM / AMPHOTERICIN B /
HYDROCORTISONE 30MG / 50MG / 5MG / 25MG 05446-1634-01 DEXAMETHASONE
IONTOPHORESIS 0.4% 05446-0622-01 DIBUTYL SQUARATE 2% 05446-1047-03 DIBUTYL
SQUARATE 1% 05446-1156-03 LIDOCAINE / TETRACAINE 23% / 7% 05446-1647-01
LIDOCAINE HCL / EPINEPHRINE / TETRACAINE HCL (LET) 4%/0.05%/0.5% 05446-0607-01
LIDOCAINE HCL / OXYMETAZOLINE 4% / 0.05% 05446-1256-01 LIDOCAINE HCL /
PRILOCAINE HCL / TETRACAINE HCL
(PROFOUND) DENTAL (RASPBERRY MARSHMALLOW) 10% / 10% / 4% 05446-0790-10 LIDOCAINE
HCL / PRILOCAINE HCL / TETRACAINE HCL
(PROFOUND) DENTAL GEL (MINT) 10% / 10% / 4% 05446-0407-10 LIDOCAINE HCL /
PRILOCAINE HCL / TETRACAINE HCL /
PHENYLEPHRINE HCL (PROFOUND-PE) DENTAL (RASPBERRY MARSHMALLOW) 10% / 10% / 4% /
2% 05446-1018-10 LIDOCAINE HCL / PRILOCAINE HCL / TETRACAINE HCL /
PHENYLEPHRINE HCL (PROFOUND-PE) DENTAL GEL (MINT) 10% / 10% / 4% / 2%
05446-0408-10 PHENOL 89% 05446-1211-03 PHENYLEPHRINE HCL / LIDOCAINE HCL 1% / 4%
05446-1045-03 PHYTONADIONE (VITAMIN K) 5 MG/ML 05446-1132-03 PROMETHAZINE HCL 25
MG / 1.2ML 05446-1341-01 TETRACAINE HCL 4% 05446-1195-03 VANCOMYCIN HCL 125 MG /
2.5ML (50 MG/ML) 05446-1348-01

--------------------------------------------------------------------------------


COMPANY CONTACT INFORMATION

Consumers: Edge Pharma, LLC 802-992-1178 Recall@edgepharma.com



   CONTENT CURRENT AS OF:
   
   12/07/2021


 * REGULATED PRODUCT(S)
   
    * Drugs


 * FOLLOW FDA
   
    * Follow @US_FDA on TwitterExternal Link Disclaimer
    * Follow FDA on FacebookExternal Link Disclaimer
    * Follow @FDArecalls on TwitterExternal Link Disclaimer
    * Recent Recalled Product Photos on FDA's Flickr PhotostreamExternal Link
      Disclaimer



More Recalls, Market
Withdrawals, &
Safety Alerts

 * Recalls, Market Withdrawals, & Safety Alerts
    * Recall Resources
   
    * Enforcement Reports
    * Industry Guidance For Recalls
    * Major Product Recalls
    * Archive for Recalls, Market Withdrawals & Safety Alerts




FOOTER LINKS

 * FDA Archive
 * About FDA
 * Accessibility

 * Visitor Information
 * Website Policies / Privacy
 * No FEAR Act

 * FOIA
 * HHS.gov
 * USA.gov

Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on
YouTube Subscribe to FDA RSS feeds
FDA Homepage
Contact Number 1-888-INFO-FDA (1-888-463-6332)

Back to Top