Xylocaine with Epinephrine FDA Alerts
The FDA Alerts below may be specifically about Xylocaine with Epinephrine or relate to a group or class of drugs which include Xylocaine with Epinephrine.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Xylocaine with Epinephrine
Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance
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.
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 |
Source: FDA
Local Anesthetics, Continuously Infused (marketed as bupivacaine, chloroprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis
FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics (marketed as bupivacaine, chloroprocaine, lidocaine, mepivacaine, procaine, ropivacaine) with elastomeric infusion devices to control post-surgical pain. The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).
Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics. Health care professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.
This notice provides further management considerations for healthcare professionals, information for patients, a data summary of the 35 reports, and references.
[11/13/2009 - Information for Healthcare Professionals - FDA]