Hurricane Helene: Baxter's manufacturing recovery in North Carolina
Information and updates on CDER-regulated drug and biologic products
What's New:
[12-12-2024]: To address the current drug shortage, B. Braun is releasing 12 lots of sodium chloride 0.9% (500ml and 1000ml). These lots are associated with primary air volume (headspace) below specification limit which could impact container fluid level monitoring during use.
[12-06-2024]: Sichuan Kelun Pharmaceutical Co., Ltd is now able to import the product listed below into the U.S. Other entities cannot legally import these products, and products from unknown sources may put your patients at risk as they may not be the ones listed below. FDA does not have authority over allocation or distribution of these products.
[12-04-2024]:
- HK Inno.N Corporation is now able to import the product listed below into the U.S. Other entities cannot legally import these products, and products from unknown sources may put your patients at risk as they may not be the ones listed below. FDA does not have authority over allocation or distribution of these products.
- ASPEN issued a practice tool on the Clinical Considerations in the Conversion of Dextrose Injection USP to Glucose 50% Injection
On this page: Parenteral Drug Products in shortage | Information on compounding | Temporary importation sources to help mitigate shortages | Previous HHS and FDA Communication | Communication from Baxter International
Parenteral Drug Products in Shortage
The following products are currently in shortage and may be further impacted until North Cove resumes operations:
- Dextrose 5% IV Solution – (shortage posted on 2/14/22)
- Dextrose 10% IV Solution – (shortage posted on 2/14/22)
- Dextrose 70% IV Solution – (shortage posted on 10/11/24)
- Lactated Ringers IV Solution – (shortage posted on 10/11/24)
- Peritoneal Dialysis Solution – (shortage posted on 10/11/24)
- Sodium Chloride 0.9% IV Solution (Normal Saline) – (shortage posted on 6/21/18)
- Sodium Chloride 0.9% for Irrigation – (shortage posted on 4/28/23)
- Sterile Water for Injection – (shortage posted on 11/23/21)
- Sterile Water for Irrigation – (shortage posted on 4/28/23)
Additional products may be added to the FDA shortage list if FDA were to determine that the total supply, including importation of product from other Baxter facilities outside the U.S., dips below national demand.
FDA has heard concerns about discarding expired intravenous fluid products and questions about possible expiration date extensions for those products. The request for extension of expiry must be submitted by the manufacturer and manufacturer-specific stability data must be reviewed by FDA. Based on stability data provided by Baxter and reviewed by FDA, the following extended use dates are supported for specific lot numbers indicated in the linked table. Providers and patients that have the lot numbers in stock will be able to use them through the corresponding new use dates to help with supply. As data become available, this list can continue to expand.
FDA is not requiring or recommending that the identified lot numbers in the linked table be relabeled with their new use dates. However, if replacement product becomes available during the extension period, then the agency expects the lots in these tables will be replaced and properly disposed of as soon as possible.
Conservation Resources
On October 28, HHS, as well as hospital and group purchasing organization industry leaders, held an informational briefing on strategies and best practices to conserve intravenous fluid (IV) products that are in shortage and may be further impacted until the North Cove facility is operational.
On October 11, CDC issued a Health Alert Network (HAN) Health Advisory to inform healthcare providers, pharmacists, health care facility administrators, and state, tribal, local, and territorial health departments of a supply disruption of IV and PD solutions from Baxter’s facility in North Carolina, due to Hurricane Helene.
Related Links:
- ASPEN's 2024 Parenteral Nutrition Product Shortage Recommendations: Intravenous Dextrose
- ASPEN's 2024 Parenteral Nutrition Product Shortage Recommendations: Sterile Water for Injection
- ASPEN practice tool on Clinical Considerations in the Conversion of Dextrose Injection USP to Glucose 50% Injection
Information on Compounding
Compounded drugs might be appropriate if a patient’s medical need cannot be met by an FDA-approved drug or the FDA-approved drug is not available. However, compounded drugs are not FDA-approved, which means they are not reviewed by FDA for safety, effectiveness or quality before they are marketed for patient use.
Compounders may make a compounded version of a drug on FDA’s drug shortages list if they meet the conditions in federal law.
- Section 503A of the FD&C Act restricts compounding, regularly or in inordinate amounts, drugs that are essentially copies of commercially available drugs. FDA does not consider a drug to be commercially available if it is on FDA’s drug shortages list.
- Section 503B of the FD&C Act restricts outsourcing facilities from making essentially a copy of an FDA-approved drug. This condition does not prohibit outsourcing facilities from preparing compounded drugs that are identical or nearly identical copies of an FDA-approved drug on the FDA’s drug shortages list.
The compounded drug has to meet other conditions in section 503A or 503B. Visit FDA’s webpage Compounding when Drugs are on FDA’s Drug Shortages List for more information.
Compounding Guidances
FDA is working continuously to address the shortages and supply disruptions to ensure patients have access to certain parenteral drugs, including intravenous solutions. The agency has issued an immediately-in-effect guidance, Temporary Policies for Compounding Certain Parenteral Drug Products, for compounders to help fill the gaps from the impact of Hurricane Helene on Baxter International’s North Cove facility.
The guidance describes that, temporarily, FDA does not intend to take action against a pharmacy, including a hospital or health system pharmacy, that is not registered as an outsourcing facility for providing certain compounded parenteral drugs to a hospital without first obtaining a patient-specific prescription, provided certain conditions are met.
Additionally, FDA does not intend to take action against an outsourcing facility for not meeting current good manufacturing practice (CGMP) requirements pertaining to product stability testing of certain parenteral drugs, provided certain conditions are met.
The agency has received some questions about its draft guidance for industry on hospital and health system compounding under section 503A. In 2021, FDA revised its draft guidance to, among other things, remove a provision about the distribution of the compounded drug beyond a one-mile radius. There is no one-mile radius policy. In addition, the new guidance—Temporary Policies for Compounding Certain Parenteral Drug Products—does not include a condition for use within 24 hours.
Related Links:
Temporary importation sources to help mitigate shortages
FDA’s Drug Shortages Staff is working with Baxter, HK Inno.N Corporation, and Sichuan Kelun Pharmaceutical Co., Ltd to confirm each product’s availability and ordering information. FDA does not have authority over allocation or distribution of these products.
Only Baxter, HK Inno.N Corporation, and Sichuan Kelun Pharmaceutical Co., Ltd are currently able to import the products listed below into the U.S. Other entities cannot legally import these products, and products from unknown sources may put your patients at risk as they may not be the ones listed below. Contact Baxter, HK Inno.N Corporation (via SLI Medical), and Sichuan Kelun Pharmaceutical Co., Ltd (via Apiject) for information about allocation levels as well as current and projected availability of these products.
Product listed from HK Inno.N Corporation
Company Contact Information: Supply Line International Medical LLC: 844-239-4058 or Info@slimedical.com
| Product Name | Presentation | Additional Information | Availability |
|---|---|---|---|
| 0.9% Sodium Chloride Injection | 9g/1000mL, NDC 84988-1440-1 | Product from South Korea | December 2024 |
Product listed from Sichuan Kelun Pharmaceutical Co., Ltd
Company Contact Information: APIJECT SYSTEMS, CORP: 239-293-3883 or lkania@pharmacyreserve.com
| Product Name | Presentation | Additional Information | Availability |
|---|---|---|---|
| 0.9% Sodium Chloride Injection | 9g/250mL, NDC 84898-911-02 | Product from Chengdu, China | December 2024 |
Products listed in the Baxter table may already be included in the manufacturer’s existing allocation calculations.
| Product Name | Presentation | Additional Information | Availability |
|---|---|---|---|
| DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose | 2,000 mL, NDC 0941-0727-01 | Product from Guangzhou, China | To be determined |
| EXTRANEAL Peritoneal Dialysis Solution with 7.5% Icodextrin | 2,000 mL, NDC 0941-0707-03 | Product from Woodlands, Singapore Important Prescribing Information | To be determined |
| Sodium Chloride 0.9% for Irrigation (UROMATIC) | 3,000 mL, NDC 0338-0110-01 | Product from Thetford, UK Important Prescribing Information | To be determined |
| Sterile Water for Injection USP | 1,000 mL, NDC 0338-9782-01 | Product from Alliston, Canada Important Prescribing Information | To be determined |
| 70% Dextrose Injection USP | 3,000 mL, NDC 0338-9789-01 | Product from Alliston Canada Important Prescribing Information | To be determined |
| EXTRANEAL (icodextrin) Solution for Peritoneal Dialysis | 2,500 mL, NDC 0941-0681-02 | Product from Castlebar, Ireland Important Prescribing Information | Estimated First Date of Supply: late November 2024 |
| DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose | 2,500 mL, NDC 0941-0684-01 | Product from Guangzhou, China Important Prescribing Information | Estimated First Date of Supply: Late December 2024 |
| DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose | 2,500 mL, NDC 0941-0688-01 | Product from Guangzhou, China Important Prescribing Information | Estimated First Date of Supply: Late December 2024 |
| DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose | 2,500 mL, NDC 0941-0692-01 | Product from Guangzhou, China Important Prescribing Information | Estimated First Date of Supply: Late December 2024 |
| DIANEAL Low Calcium Peritoneal Dialysis Solution (Lactate-G 1.5%) | 2,000 mL, NDC 0941-0686-01 | Product from Guangzhou, China Important Prescribing Information | Estimated First Date of Supply: mid November 2024 |
| DIANEAL Low Calcium Peritoneal Dialysis Solution (Lactate-G 2.5%) | 2,000 mL, NDC 0941-0690-01 | Product from Guangzhou, China Important Prescribing Information | Estimated First Date of Supply: mid November 2024 |
| DIANEAL Low Calcium Peritoneal Dialysis Solution (Lactate-G 4.25%) | 2,000 mL, NDC 0941-0694-01 | Product from Guangzhou, China Important Prescribing Information | Estimated First Date of Supply: mid December 2024 |
| 0.9% Sodium Chloride Injection | 250 mL, NDC 0338-9791-01 | Product from Shanghai, China Important Prescribing Information | Estimated First Date of Supply: early December 2024 |
| 0.9% Sodium Chloride Injection | 1,000 mL, NDC 0338-9793-01 | Product from Shanghai, China Important Prescribing Information | Estimated First Date of Supply: late November 2024 |
| 5% Glucose Injection | 250 mL, NDC 0338-9795-01 | Product from Shanghai, China Important Prescribing Information | To be determined |
| 5% Glucose Injection | 1,000 mL, NDC 0338-9801-01 | Product from Shanghai, China Important Prescribing Information | To be determined |
| 10% Glucose Injection | 250 mL, NDC 0338-9797-01 | Product from Shanghai, China Important Prescribing Information | To be determined |
| 5% Glucose and 0.9% Sodium Chloride Injection | 1,000 mL, NDC 0338-9799-01 | Product from Shanghai, China Important Prescribing Information | To be determined |
| 50% Glucose Injection | 3,000 mL, NDC 0338-9787-01 | Product from Thetford, UK Important Prescribing Information | To be determined |
| 70% Glucose Injection | 500 mL, NDC 0338-9785-01 | Product from Thetford, UK Important Prescribing Information | To be determined |
| 0.9% Sodium Chloride Injection in VIAFLEX Plastic | 250 mL, NDC 0338-9804-01 | Product from Shanghai, China Important Prescribing Information | Estimated First Date of Supply: Early November 2024 |
| 0.9% Sodium Chloride Injection | 500 mL, NDC 0338-9810-01 | Product from Shanghai, China Important Prescribing Information | Estimated First Date of Supply: Early November 2024 |
| 0.9% Sodium Chloride Injection in VIAFLEX Plastic | 1,000 mL, NDC 0338-9806-01 | Product from Shanghai, China Important Prescribing Information | Estimated First Date of Supply: Early November 2024 |
| 0.9% Sodium Chloride Injection | 500 mL, NDC 0338-9808-01 | Product from Shanghai, China Important Prescribing Information | Estimated First Date of Supply: Late December 2024 |
| DIANEAL PD4 Glucose 1.36% w/v / 13.6 mg/mL Solution for Peritoneal Dialysis | 5,000 mL, NDC 0941-0484-03 | Product from Castlebar, Ireland Important Prescribing Information | Estimated First Date of Supply: mid November 2024 |
| DIANEAL PD4 Glucose 2.27% w/v / 22.7 mg/mL Solution for Peritoneal Dialysis | 5,000 mL, NDC 0941-0487-05 | Product from Castlebar, Ireland Important Prescribing Information | Estimated First Date of Supply: late November 2024 |
| DIANEAL PD4 Glucose 3.86% w/v / 38.6 mg/mL Solution for Peritoneal Dialysis | 5,000 mL, NDC 0941-0490-07 | Product from Castlebar, Ireland Important Prescribing Information | Estimated First Date of Supply: late November 2024 |
| DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose | 2,000 mL, NDC 0941-0698-01 | Product from Guangzhou, China Important Prescribing Information | Estimated First Date of Supply: mid November 2024 |
| DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose | 2,000 mL, NDC 0941-0696-01 | Product from Guangzhou, China Important Prescribing Information | Estimated First Date of Supply: late November 2024 |
| DIANEAL PD4 Glucose 2.27% w/v / 22.7 mg/mL Solution for Peritoneal Dialysis | 2,500 mL, NDC 0941-0457-06 | Product from Castlebar, Ireland Important Prescribing Information | Estimated First Date of Supply: early December 2024 |
| DIANEAL PD-4 Low Calcium with 1.5% Dextrose | 2,000 mL, NDC 0941-0711-01 | Product from Amata, Thailand Important Prescribing Information | Estimated First Date of Supply: Early November 2024 |
| DIANEAL PD-4 Low Calcium with 2.5% Dextrose | 2,000 mL, NDC 0941-0713-01 | Product from Amata, Thailand Important Prescribing Information | Estimated First Date of Supply: Early November 2024 |
| DIANEAL PD-4 Low Calcium with 4.25% Dextrose | 2,000 mL, NDC 0941-0715-01 | Product from Amata, Thailand Important Prescribing Information | Estimated First Date of Supply: Late December 2024 |
| DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose | 6,000 mL, NDC 0941-0701-01 | Product from Guangzhou, China Important Prescribing Information | Estimated First Date of Supply: mid December 2024 |
| DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose | 6,000 mL, NDC 0941-0703-01 | Product from Guangzhou, China Important Prescribing Information | Estimated First Date of Supply: mid December 2024 |
| EXTRANEAL 7.5% w/v Icodextrin Peritoneal Dialysis Solution | 2,500 mL, NDC 0941-0709-01 | Product from Alliston, Canada Important Prescribing Information | To be determined |
| EXTRANEAL (icodextrin) Solution for Peritoneal Dialysis | 2,000 mL, NDC 0941-0719-01 | Product from Castlebar, Ireland Important Prescribing Information | Estimated First Date of Supply: early November 2024 |
| EXTRANEAL (icodextrin) Solution for Peritoneal Dialysis | 2,500 mL, NDC 0941-0681-02 | Product from Castlebar, Ireland Important Prescribing Information | Estimated First Date of Supply: late November 2024 |
| EXTRANEAL (icodextrin) Solution for Peritoneal Dialysis | 2,000 mL, NDC 0941-0717-01 | Product from Castlebar, Ireland Important Prescribing Information | Estimated First Date of Supply: early November 2024 |
| EXTRANEAL (icodextrin) Solution for Peritoneal Dialysis | 2,500 mL, NDC 0941-0681-01 | Product from Castlebar, Ireland Important Prescribing Information | Estimated First Date of Supply: late November 2024 |
| DIANEAL PD4 Glucose 1.36% w/v / 13.6 mg/mL Solution for Peritoneal Dialysis | 2,500 mL, NDC 0941-0409-06 | Product from Castlebar, Ireland Important Prescribing Information | Estimated First Date of Supply: early December 2024 |
| DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose | 5,000 mL, NDC 0941-0705-01 | Product from Woodlands, Singapore Important Prescribing Information | Estimated First Date of Supply: early December 2024 |
| EXTRANEAL Peritoneal Dialysis Solution with 7.5% Icodextrin | 2,000 mL, NDC 0941-0707-01 | Product from Woodlands, Singapore Important Prescribing Information | Estimated First Date of Supply: mid November 2024 |
| Plasma-Lyte 148 (pH 7.4) Solution for Infusion | 1,000 mL, NDC 0338-9593-01 | Product from Sabinanigo, Spain Important Prescribing Information | To be determined |
| 0.9% Sodium Chloride Injection | 250 mL, NDC 0338-9604-01 | Product from Alliston, Canada Important Prescribing Information | To be determined |
| 0.9% Sodium Chloride Injection | 500 mL, NDC 0338-9608-01 | Product from Alliston, Canada Important Prescribing Information | To be determined |
| 0.9% Sodium Chloride Injection | 500 mL, NDC 0338-9608-01 | Product from Alliston, Canada Important Prescribing Information | To be determined |
| 5% Dextrose Injection | 250 mL, NDC 0338-9830-01 | Product from Alliston, Canada Important Prescribing Information | To be determined |
| 5% Dextrose Injection | 1,000 mL, NDC 0338-9588-01 | Product from Alliston, Canada Important Prescribing Information | To be determined |
| Lactated Ringer's Injection | 500 mL, NDC 0338-9596-01 | Product from Alliston, Canada Important Prescribing Information | To be determined |
| Lactated Ringer's Injection | 1,000 mL, NDC 0338-9600-01 | Product from Alliston, Canada Important Prescribing Information | To be determined |
| Plasma-Lyte A Injection | 1,000 mL, NDC 0338-9591-01 | Product from Alliston, Canada Important Prescribing Information | To be determined |
| Sodium Lactate Ringer’s Injection | 500 mL, NDC 0338-9832-01 | Product from Shanghai, China Important Prescribing Information | To be determined |
| 0.9% Sodium Chloride Irrigation, USP (UROMATIC) | 3,000 mL, NDC 0338-9834-01 | Product from Alliston, Canada Important Prescribing Information | To be determined |
Previous HHS and FDA Communication
[12-03-24]: To address a potential drug shortage, Baxter is releasing one lot of sodium citrate 4% (250ml) manufactured at the North Cove facility prior to Hurricane Helene. This lot is associated with a small proportion of bags with an illegible lot number. Because there are a small number of bags in this one impacted lot that may experience this defect, this one lot is being released to mitigate a potential drug shortage. The specific impacted lot is:
- Sodium Citrate 4% (250 ml) anticoagulant sodium citrate, Lot # Y451048
[11-25-2024]: B. Braun Medical Inc. is releasing eight lots of 0.9% Sodium Chloride Injection, USP with overwrap defects to address the current drug shortage. Health care professionals should apply pressure to each bag and inspect them for leakage or signs of leakage before using products from these lots. Additionally, check to see that solution is clear and free of foreign matter, and discard the affected bag if the solution is not clear. For more information on the impacted lots and photos of the defect, read the Dear Health Care Provider Letter.
[11-21-24]: FDA held an informational briefing on the status of the IV fluid shortages, and provided recommendations for health care professionals to check for leaks when using IV fluid products from certain lots where leak defects have been identified.
[11-20-24]: To address current drug shortages, Baxter is releasing four lots of IV fluid bags manufactured at the North Cove facility prior to Hurricane Helene associated with a very small proportion of leaks while those leaks are under investigation. Because there are just a small number of bags in each impacted lot that may experience this defect, these lots are being released with instructions for health care professionals to screen the bags for leaks prior to use and to discard IV fluid bags that have any evidence of leakage. Any leak would most likely be presented as an obvious defect before handling, and/or would present itself as an obvious defect once pressure is applied. Specific impacted lots are:
- 0.9% Sodium Chloride Injection USP (500 mL), Lot # Y456227
- 0.9% Sodium Chloride Injection USP (1000 mL), Lot # Y455404
- Extraneal PD-2 (Icodextrin) Peritoneal Dialysis Solution, Lot # Y454315
- Plasma-Lyte A Injection pH 7.4, Lot # Y449571
Health care professionals should apply pressure to each bag and inspect them for leakage or signs of leakage before using products from these lots. Additionally, check to see that solution is clear and free of foreign matter, and discard the affected bag if the solution is not clear.
[10-28-24]: FDA announced extended use dates for some parenteral drug products, after a review of the stability data submitted by Baxter International. Providers and patients that have the lot numbers in stock will be able to use them through the corresponding new use dates to help with supply. The following extended use dates are supported for specific lot numbers indicated in the linked table.
[10-24-2024] Statement from Secretary Xavier Becerra on IV Fluid Increase
[10-18-2024] Fact Sheet: HHS Continues Taking Action to Increase Access and Supply of IV Fluids Following Hurricane Helene
[10-11-24] FDA has released an immediately-in-effect guidance titled “Temporary Policies for Compounding Certain Parenteral Drug Products”. Please see the Information on Compounding section for more information.
FDA has added three new parenteral drug products to the Drug Shortages Database. The agency now considers Dextrose 70% IV solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution to not be commercially available in adequate supply to meet national demand.
[10-9-2024] Letter to Health Care Leaders and Stakeholders on Impacts of Hurricane Helene from Secretary Becerra
[10-9-24] FDA is working to temporarily import some products in shortage to help meet patient needs. In this situation, we very carefully assess the overseas product for quality, making sure that it is safe for U.S. patients. Please see the table for more information.
FDA’s Drug Shortages Staff is working with the manufacturer(s) to confirm each product’s availability and ordering information, and will update the table as the information becomes available.
[10-1-2024] FDA is aware of the devastating impact Hurricane Helene had to Baxter International’s North Cove manufacturing facility in Marion, North Carolina. Our thoughts go out to the community and to Baxter’s employees during this difficult time.
This facility is one of the largest manufacturers of intravenous and peritoneal dialysis solutions in the United States. FDA is actively working with Baxter and our colleagues in HHS and across government to confirm how much product was recently released for distribution, or may be available at wholesalers, and provide any resources and assistance we can during this time. This could include reviewing potential temporary imports or expediting reviews of the cleaned and restored manufacturing lines.
As of October 1, 2024, FDA has not declared any new shortages related to products produced at the North Cove facility. While Baxter is taking new steps to manage inventory of their North Cove presentations to assure equitable access, FDA is also working with Baxter’s additional facilities to increase supply and reduce the risk of new shortages until Baxter can resume manufacturing the impacted products. FDA will also be working with alternative suppliers, as needed, to manage gaps/shortages in supply of critical products.
Communications from Baxter International
- Baxter’s Newsroom
- Expiration Dating Extension Medical Information
- Dear Customer Letter: Update on Baxter’s North Cove, NC Facility (9-29-2024)
- Dear Customer Letter: Medical Information Letter for Healthcare Facilities (9-30-2024)
- Dear Customer Letter: Medical Information Letter for Home Dialysis Customers (10-1-2024)
Contact CDER
If you have a question about drug shortages, email drugshortages@fda.hhs.gov.
For all other questions, email druginfo@fda.hhs.gov or call (301) 796-3400 or (855) 543-3784.