Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Hospira Issues a Voluntary Nationwide Recall For 8.4% Sodium Bicarbonate Injection, USP, Neut tm (Sodium Bicarbonate 4% Additive Solution), QUELICIN tm (Succinylcholine Chloride Injection, USP) and Potassium Phosphates Injection, USP Due To a Potential For Lack Of Sterility Assurance

For Immediate Release

June 15, 2017

Contact

Consumers

1-888-345-4680

Media

610-329-1340

Announcement

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.

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. Hospira places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.

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; and 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.i See Appendix for lots and packaging information.

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.

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.

For clinical inquiries, please contact Hospira using the information provided below.

Hospira ContactContact InformationAreas of Support
Pfizer Complaint Management1-800-438-1985 (24 hours a day 7 days per week)To report adverse events or product complaints
Pfizer Medical Information1-800-615-0187 (8am to 7pm EST Monday through Friday)Medical inquiries

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.


Appendix: Lots and Packaging Information

8.4% Sodium Bicarbonate Inj., USP

NDCLot NumbersExpiration DateStrengthConfiguration/Count
0409-6625-0272109EV12/01/20188.40% 50ml1X25 VL
72110EV12/01/20188.40% 50ml1X25 VL
72112EV12/01/20188.40% 50ml1X25 VL
72113EV12/01/20188.40% 50ml1X25 VL
72114EV12/01/20188.40% 50ml1X25 VL
72120EV12/01/20188.40% 50ml1X25 VL
73068EV01/01/20198.40% 50ml1X25 VL
73071EV01/01/20198.40% 50ml1X25 VL
73072EV01/01/20198.40% 50ml1X25 VL
73224EV01/01/20198.40% 50ml1X25 VL
73225EV01/01/20198.40% 50ml1X25 VL
73230EV01/01/20198.40% 50ml1X25 VL
73231EV01/01/20198.40% 50ml1X25 VL
73232EV01/01/20198.40% 50ml1X25 VL
73233EV01/01/20198.40% 50ml1X25 VL
73234EV01/01/20198.40% 50ml1X25 VL
73235EV01/01/20198.40% 50ml1X25 VL
73236EV01/01/20198.40% 50ml1X25 VL
73298EV01/01/20198.40% 50ml1X25 VL
74058EV02/01/20198.40% 50ml1X25 VL
74104EV02/01/20198.40% 50ml1X25 VL
74105EV02/01/20198.40% 50ml1X25 VL
74106EV02/01/20198.40% 50ml1X25 VL
74107EV02/01/20198.40% 50ml1X25 VL
74197EV02/01/20198.40% 50ml1X25 VL
74198EV02/01/20198.40% 50ml1X25 VL
74199EV02/01/20198.40% 50ml1X25 VL
74200EV02/01/20198.40% 50ml1X25 VL
74201EV02/01/20198.40% 50ml1X25 VL
75171EV03/01/20198.40% 50ml1X25 VL
75172EV03/01/20198.40% 50ml1X25 VL
75173EV03/01/20198.40% 50ml1X25 VL
75174EV03/01/20198.40% 50ml1X25 VL
75175EV03/01/20198.40% 50ml1X25 VL
75176EV03/01/20198.40% 50ml1X25 VL
75177EV03/01/20198.40% 50ml1X25 VL
75178EV03/01/20198.40% 50ml1X25 VL
75293EV03/01/20198.40% 50ml1X25 VL
75418EV03/01/20198.40% 50ml1X25 VL
75419EV03/01/20198.40% 50ml1X25 VL

Neut™ Sodium Bicarbonate additive solution 4%

NDCLot NumbersExpiration DateStrengthConfiguration/Count
0409-6609-2575386EV03/1/20194%/5ML1X25 FTV NOVA PLUS
0409-6609-0272226EV12/01/20184%/5ML1X25 FTV
0409-6609-0272236EV12/01/20184%/5ML1X25 FTV
0409-6609-0275382EV03/01/20194%/5ML1X25 FTV
0409-6609-0275383EV03/01/20194%/5ML1X25 FTV

Succinylcholine Chloride Injection, USP/Quelicin®

NDCLot NumbersExpiration DateStrengthConfiguration/Count
0409-6629-0274393EV05/01/2018200mg/10ml1X25 FTV
0409-6629-0275157EV
75367EV
06/01/2018
06/01/2018
200mg/10ml1X25 FTV
0409-6629-2575158EV06/01/2018200mg/10ml1X25 FTV NOVA PLUS
0409-6629-0275367EV06/01/2018200mg/10ml1X25 FTV

Potassium Phosphates Injection, USP

NDCLot NumbersExpiration DateStrengthConfiguration/Count
0409-7295-0174119EV02/01/201945mM25X15ML
0409-7295-0174120EV02/01/201945mM25X15ML
0409-7295-0174121EV02/01/201945mM25X15ML
0409-7295-0174307EV02/01/201945mM25X15ML
0409-7295-0175326EV03/01/201945mM25X15ML
0409-7295-0175327EV03/01/201945mM25X15ML
0409-7295-0175215EV03/01/201945mM25X15ML

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Page Last Updated: 06/22/2017
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