Aerodine FDA Alerts
The FDA Alerts below may be specifically about Aerodine or relate to a group or class of drugs which include Aerodine.
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 Aerodine
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
H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing
Multiple brands affected - listed below
[UPDATED 09/18/2012] Custom Medical Specialties, Inc., Custom HSG Tray, Hysteroscopic Sterilization Pack, Custom Vein Tray, Custom Amnio Tray, Fox Chase Specials Pack, Abington Radiology Drainage Pack, Custom CT Biopsy Tray, HSG Tray, Custom Myelogram Tray, and Hysteroscopy Sterile Procedure Kit. Class 1 Recall. The custom surgical kits contain Povidone Iodine Prep solution that had previously been recalled by H & P Industries, Inc. The manufacturer did not conduct any microbial testing and the products did not meet proper finished specifications. These products may cause serious adverse health consequences, including death. See the Recall Notice for a listing of affected brand names and lot numbers.
[Posted 08/27/2011]
ISSUE: H & P Industries and FDA notified health professionals and the public of a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. This recall has been initiated at the request of FDA.
BACKGROUND: Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel are labeled as an antiseptic for preparation of the skin prior to surgery, and are used to prevent infection in minor cuts, scrapes and burns. The Povidone Iodine Scrub solutions are labeled also for use as a surgical hand scrub for health care professionals. The Povidone Iodine products were distributed nationwide to healthcare customers. The swabsticks are packaged in individual packets of 1 or 3 swabs and the Prep Solution, Scrub Solution and Prep Gel are sold in bottles.
RECOMMENDATION: Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased.
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
H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination
Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources, Atwater Carey, Lee Medical International, NAR Surgical
[UPDATED 02/08/2012] NAR Surgical Crichothyroidotomy Kit or Crickit kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.
[UPDATED 10/03/2011] Additional Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.
[UPDATED 09/16/2011] Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.
[UPDATED 05/03/2011] Consumers using one of the affected First Aid Kits should immediately dispose of the Triad Povidone Iodine Prep Pads included in the First Aid Kits.
[Posted 03/18/2011]
ISSUE: H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidone Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidone Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections.
BACKGROUND: Povidone Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets.
RECOMMENDATION: Healthcare organizations should contact H&P Industries Customer Service to arrange a return. If a consumer has any of these types of products in their possession, they should not use the product.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination
Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources, Atwater Carey, Lee Medical International
[UPDATED 10/03/2011] Additional Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.
[UPDATED 09/16/2011] Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.
[UPDATED 05/03/2011] Consumers using one of the affected First Aid Kits should immediately dispose of the Triad Povidone Iodine Prep Pads included in the First Aid Kits.
[Posted 03/18/2011]
ISSUE: H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidone Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidone Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections.
BACKGROUND: Povidone Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets.
RECOMMENDATION: Healthcare organizations should contact H&P Industries Customer Service to arrange a return. If a consumer has any of these types of products in their possession, they should not use the product.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination
Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources, Atwater Carey, Lee Medical International
[UPDATED 09/16/2011] Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.
[UPDATED 05/03/2011] Consumers using one of the affected First Aid Kits should immediately dispose of the Triad Povidone Iodine Prep Pads included in the First Aid Kits.
[Posted 03/18/2011]
ISSUE: H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidone Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidone Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections.
BACKGROUND: Povidone Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets.
RECOMMENDATION: Healthcare organizations should contact H&P Industries Customer Service to arrange a return. If a consumer has any of these types of products in their possession, they should not use the product.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing
ISSUE: H & P Industries and FDA notified health professionals and the public of a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. This recall has been initiated at the request of FDA.
BACKGROUND: Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel are labeled as an antiseptic for preparation of the skin prior to surgery, and are used to prevent infection in minor cuts, scrapes and burns. The Povidone Iodine Scrub solutions are labeled also for use as a surgical hand scrub for health care professionals. The Povidone Iodine products were distributed nationwide to healthcare customers. The swabsticks are packaged in individual packets of 1 or 3 swabs and the Prep Solution, Scrub Solution and Prep Gel are sold in bottles.
RECOMMENDATION: Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased.
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
[08/24/2011 - Press Release - H&P Industries, Inc]
Swabsticks
Amerinet
Cardinal Health
Nova Plus
PSS Select
Triad
Triad Plus
Prep Solutions
American Fare
Amerinet
Equaline
Fred's
Good Neighbor
Good Sense
Laura Lynn
Leader
Major
Meijer
Nova Plus
Premiere Value
PSS Select
Triad
Triad Plus
Walgreens
Winn Dixie
Gel
Triad Plus
Scrub
Amerinet
Nova Plus
Triad
Triad Plus
H & P Industries Povidine Iodine Prep Pads: Recall - Potential Microbial Contamination
Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources
[Posted 03/18/2011]
ISSUE: H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidine Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidine Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections.
BACKGROUND: Povidine Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets.
RECOMMENDATION: Healthcare organizations should contact H&P Industries Customer Service to arrange a return. If a consumer has any of these types of products in their possession, they should not use the product.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems 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
[03/15/2011 - Press Release - H&P Industries, Inc.]