Induction Therapies, LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | ||||
Golden Medal Mushroom Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||||
Synaptent, LLC | Office of Human and Animal Food Operations-East 6 | New Drug/Misbranded | ||||
Roal Produce, Inc | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
Rip It Vapors | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
Eagle Energy USA, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | ||||
Honest Living Vape Shoppe & Apothecary | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
Yogi's Vape Lounge | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
E Cig Zone Inc | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
The Zen Vaper E-Liquids, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, December 9, 2021
Victory Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
Vapor Nuvola | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
Jayde’s Vapor Lounge | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
You Suck Vapes | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
Sabra Dipping Company, LLC | Division of Human and Animal Food Operations East II | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | ||||
Vape Craft Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
VitaStik, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | ||||
VitaCig, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | ||||
NV Nutrition, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | ||||
Vitamin Vape, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance
Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
- 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:
- Edge Pharma, LLC
- 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
- quoted from FDA website found here