Fortaz FDA Alerts
The FDA Alerts below may be specifically about Fortaz or relate to a group or class of drugs which include Fortaz.
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 Fortaz
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
B. Braun Medical Inc. Issues Voluntary Nationwide Recall of One (1) Lot of Ceftazidime for Injection USP and Dextrose Injection USP (50 mL), Duplex Container Due to Out-of-Specification Results for High Molecular Weight Polymers
April 20, 2020 -- Braun Medical Inc. (B. Braun) is voluntarily recalling one (1) lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container to the hospital/user level.. During stability testing of Batch H8J812, test results were found to exceed the specification limits for High Molecular Weight Polymers (HMWP) at the nineteen (19) month [82 week] stability interval.
Elevated levels of High Molecular Weight Polymers have been shown to cause kidney damage and liver issues in animal studies. While the impact of HMWP in humans is unknown, B. Braun is initiating this voluntary recall out of an abundance of caution to prevent any risks of adverse reactions due to the elevated HMWP levels. To date there have been no complaints or reports of adverse reactions associated with this product lot.
Ceftazidime for Injection USP and Dextrose Injection USP is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: Lower respiratory tract infections; skin and skin-structure infections; bacterial septicemia; bone and joint infections; gynecologic infections; intra-abdominal infections; and central nervous system infections.
Ceftazidime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container containing approximately 50 mL of 5% Dextrose Injection in the diluent chamber and ceftazidime in the drug powder chamber. After reconstitution, the concentration is equivalent to 2 g ceftazidime. Ceftazidime for Injection USP and Dextrose Injection USP is packaged in 24 DUPLEX® Containers per case. The affected recalled product includes the following lot number and expiration date:
| NDC | ref | Dose/Volume | Impacted Batch | Expiration Date |
|---|---|---|---|---|
| 0264-3145-11 | 3145-11 | 2 g per 50 mL | H8J812 | 31 Jul 2020 |
Product was distributed Nationwide within the United States to domestic distributors. Pictures of the product and product labeling follow this press release.
B. Braun is notifying its distributors and customers by an official recall notice sent via certified registered mail and is arranging for return of all recalled products. Facilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 800-227-2862 Monday through Friday, 8 a.m. – 6 p.m. EST to arrange for product return.
Facilities with questions regarding this recall can contact B. Braun by phone at 800-227-2862 Monday through Friday, 8 a.m. – 6 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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.
About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, PA and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, explore our website.
Source: FDA
