Levophed FDA Alerts
The FDA Alerts below may be specifically about Levophed or relate to a group or class of drugs which include Levophed.
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 Levophed
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
Hydromorphone HCl Injection, USP 2 mg/mL, and Levophed (Norepinephrine Bitartrate Injection, USP) 4 mg/4 mL (1 mg/mL) Vial by Hospira: Recall - Lack of Sterility Assurance
ISSUE: Hospira is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII 2 mg/mL and four lots of Levophed (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
The possibility of a breach in sterility assurance in distributed product, while not confirmed, cannot be eliminated. No batches of product have been identified as containing microorganisms. To date, Hospira has not received reports of any adverse events associated with this issue for these lots. See the press release for lot numbers recalled.
In the event that impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur.
BACKGROUND: Hydromorphone Hydrochloride Injection, USP, CII is indicated for the relief of moderate to severe pain. Levophed (Norepinephrine Bitartrate Injection, USP) is indicated in adults for blood pressure control in certain acute hypotensive states.
RECOMMENDATION: Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine immediately. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital level.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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
[08/31/2017 - Press Release - Hospira]
4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag by Pharmedium: Recall - Discoloration
ISSUE: PharMEDium Services, LLC is voluntarily recalling 29 lots of 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 3 lots of 8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag distributed to hospital customers. They have received complaints from hospitals for products that have been found to exhibit a slight discoloration in the admixture.
Discoloration is indicative of degradation and could result in decreased potency due to oxidation of Norepinephrine Bitartrate. Decreased potency may result in a delayof achieving desired therapeutic effect. PharMEDium Services has not received any reports of adverse events to date related to this recall.
BACKGROUND: The product is used for blood pressure control in certain acute hypotensive states and is packaged in a 250 mL Viaflex Bag.
RECOMMENDATION: Hospital pharmacies that have the recalled 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag in stock should stop using and discard per the hospital destruction policy. Hospitals that may have shared these products with other hospitals should contact those hospitals that received the products.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch SafetyInformation and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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
