Sterile water FDA Alerts
The FDA Alerts below may be specifically about sterile water or relate to a group or class of drugs which include sterile water.
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 sterile water
Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate
May 04, 2021 -- Hospira, Inc., a Pfizer company, is voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate.
Hospira’s assessment of the potential risk to patients concluded that in rare instances the use of the impacted product can be associated with potential adverse events such as anaphylaxis, fever, gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot.
Sterile Water for Injection USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous,
intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. The NDC, Lot Number, Expiration Date, and Configuration details for Sterile Water for Injection, USP, is indicated in the table below and a photo of the product can be found at the end of this press release. The product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020.
| Product | NDC | Lot Number | Expiration Date | Presentation | Configuration /Count |
|---|---|---|---|---|---|
| Sterile Water for Injection, USP 100 mLbr Single-dose Glass Fliptop Vial |
Vial: 0409-4887-25 Carton: 0409-4887-99 |
DN9185 | 01 Apr 2023 | 100 mL, Single-dose Glass Fliptop Vial | Tray of 25 vials |
Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira, Inc. has notified wholesalers/ distributors/hospitals by letter to arrange for return of any recalled product.
Wholesalers, distributors or hospitals with an existing inventory of the lot, which is being recalled, should stop use and distribution and quarantine immediately. If you have further distributed the recalled product, to the wholesale or hospital level/institution, please notify any accounts or additional locations which may have received the recalled product from you. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.
| Contact Center | Contact Information | Area of Support |
|---|---|---|
| Pfizer Medical Information | 800-438-1985, option 3 |
For medical questions regarding the product |
| Pfizer Drug Safety | 800-438-1985, option 1 (24 hours a day; 7 days a week) |
To report adverse events and product complaints |
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.
Source: FDA
Hospira, Inc., Issues A Voluntary Nationwide Recall for One Lot of Bacteriostatic Water for Injection, USP, due to a Potential Lack of Sterility Assurance
September 6, 2019 -- Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot.
In the event that impacted product is administered to a patient, there is an increased risk that severe adverse events such as invasive bacterial infection, including bacterial meningitis, septicemia, and limited adverse events such as fever, chills, malaise, and cutaneous abscess may occur. To date, Hospira has not received reports of any such adverse events associated with this issue for this lot.
BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial is packaged as described below. Product was distributed in the and Puerto Rico to Hospitals/Retailers from March 2018, to April 2018.
| NDC | Lot Number | Expiration Date | Presentation | Configuration/Count |
|---|---|---|---|---|
| Vial: 0409-3977-01 Carton: 0409-3977-03 |
W20308 | 01 DEC 2019 | 30 mL, Multiple dose | 4 x 25 x 30mL vials |
Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira is notifying its direct customers via a recall letter to arrange for return of any recalled product.
Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine immediately. Inform Healthcare Professionals in your organization of this recall. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
For clinical inquiries please contact Pfizer using the below information.
| Contact | Contact Information | Areas of Support |
|---|---|---|
| Pfizer Medical Information | 1-800-438-1985, option 3 (9am to 5pm ET Monday through Friday) |
For Medical questions regarding this product |
| Pfizer Drug Safety | 1-800-438-1985, option 1 (24 hours a day 7 days per week) | To report adverse events or product complaints |
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 executed with the knowledge of the U.S. Food and Drug Administration.
Source: FDA
