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sodium bicarbonate FDA Alerts

The FDA Alert(s) below may be specifically about sodium bicarbonate or relate to a group or class of drugs which include sodium bicarbonate.

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. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for sodium bicarbonate

Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance

Aug 18, 2017

Audience: Health Care Professionals

[Posted 08/18/2017]

ISSUE: Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide.

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events.
 
BACKGROUND: The affected products include all lots distributed April 17, 2017, to August 10, 2017, remaining within expiry, and they would be packaged in a syringe, vial or eye dropper. For a list of products affected by this recall see the Firm Press Release.

RECOMMENDATION: Bella Pharmaceuticals is notifying its customers by email and phone, and is arranging for the return of all recalled products. Anyone with product subject to the recall should stop using it and contact the company. To return medication or request assistance related to this recall, contact Bella Pharmaceuticals at 877-235-5279, Monday through Friday, between 9 a.m. and 5 p.m. CST.

Health care professionals  are encouraged to report any adverse events to FDA’s MedWatch 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.


[08/18/2017- Press Release - Bella Pharmaceuticals]

Sodium Bicarbonate Injection 8.4 Percent USP, Neut (Sodium Bicarbonate 4 Percent Additive Solution), Quelicin (Succinylcholine Chloride Injection USP), and Potassium Phosphates Injection by Hospira: Recall - Potential For Lack Of Sterility Assurance

Jun 15, 2017

Audience: Pharmacy, Critical Care Medicine, Nursing

ISSUE: Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products. Please view the recall notice for a list of the affected lot numbers.

In the event that impacted product is administered to a patient, there is a reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Hospira has not received reports of any adverse events associated with this issue.

These lots were distributed nationwide in the U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore to wholesalers and hospitals from January to June 2017. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
 
Pfizer is working diligently to restore supply of these products and is in communication with the FDA to address any supply issues.

BACKGROUND: Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis; in the treatment of certain drug intoxications, in poisoning by salicylates or methyl alcohol and in certain hemolytic reactions. Sodium bicarbonate is indicated in severe diarrhea, which is often accompanied by significant loss of bicarbonate. NeutTM (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the pH of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion.

QuelicinTM (Succinylcholine Chloride Injection, USP) is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Potassium Phosphates Injection, USP 3 mM P/mL (millimoles/mL) is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

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/retail level. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. 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 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:


[06/15/2017 - Recall Notice - Hospira, a Pfizer company]

[06/15/2017 - CDER Statement- Updates on Pfizer drug shortages - FDA]

Sodium Bicarbonate Injection, USP by Hospira: Recall - Particulate Matter

Mar 21, 2016

Audience: Pharmacy, Nursing

ISSUE: Hospira, Inc. is recalling one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02, Lot 56-148-EV, Expiry 1AUG2017) at the hospital/retail level due to the presence of a particulate within a single–dose glass fliptop vial. The issue was identified through a confirmed complaint.

The product is packaged 50 mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50mL, Single-dose, packaged 4 boxes of 25 vials per case. The lot was distributed nationwide in the U.S. to wholesalers and hospitals in December 2015.

If the particulate is not observed prior to IV administration and breaks off into smaller particulates, passing through the catheter, it may result in localized inflammation, allergic reaction, including anaphylaxis, granuloma formation or microembolic effects (IV only). Larger particulates may block the infusion of solution, potentially resulting in a delay in therapy.

BACKGROUND: Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis; in the treatment of certain drug intoxications, in poisoning by salicylates or methyl alcohol and in certain hemolytic reactions. Sodium bicarbonate also is indicated in severe diarrhea, which is often accompanied by significant loss of bicarbonate.

RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product 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/retail level. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. For additional assistance, call Stericycle at 1-888-965-6077 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday. For clinical inquiries, please contact Hospira using the information provided in the press release.

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:


[03/18/2016 - Press Release - Hospira]

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