Summary

Company Announcement Date: June 15, 2017 FDA Publish Date: February 06, 2018 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to microbial growth Company Name: Hospira Inc, A Pfizer Company Brand Name: Brand Name(s) Hospira Product Description: Product Description 8.4% Sodium Bicarbonate Injection, USP, NeutTM (Sodium Bicarbonate 4% additive solution), QUELICINTM (Succinylcholine Chloride Injection, USP) and Potassium Phosphates Injection, USP

Company 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 Contact Contact Information Areas of Support Pfizer Complaint Management 1-800-438-1985 (24 hours a day 7 days per week) To report adverse events or product complaints Pfizer Medical Information 1-800-615-0187 (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.

Complete and submit the report Online :www.fda.gov/medwatch/report.htm

:www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htmor 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.

Appendix: Lots and Packaging Information

8.4% Sodium Bicarbonate Inj., USP

NDC Lot Numbers Expiration Date Strength Configuration/Count 0409-6625-02 72109EV 12/01/2018 8.40% 50ml 1X25 VL 72110EV 12/01/2018 8.40% 50ml 1X25 VL 72112EV 12/01/2018 8.40% 50ml 1X25 VL 72113EV 12/01/2018 8.40% 50ml 1X25 VL 72114EV 12/01/2018 8.40% 50ml 1X25 VL 72120EV 12/01/2018 8.40% 50ml 1X25 VL 73068EV 01/01/2019 8.40% 50ml 1X25 VL 73071EV 01/01/2019 8.40% 50ml 1X25 VL 73072EV 01/01/2019 8.40% 50ml 1X25 VL 73224EV 01/01/2019 8.40% 50ml 1X25 VL 73225EV 01/01/2019 8.40% 50ml 1X25 VL 73230EV 01/01/2019 8.40% 50ml 1X25 VL 73231EV 01/01/2019 8.40% 50ml 1X25 VL 73232EV 01/01/2019 8.40% 50ml 1X25 VL 73233EV 01/01/2019 8.40% 50ml 1X25 VL 73234EV 01/01/2019 8.40% 50ml 1X25 VL 73235EV 01/01/2019 8.40% 50ml 1X25 VL 73236EV 01/01/2019 8.40% 50ml 1X25 VL 73298EV 01/01/2019 8.40% 50ml 1X25 VL 74058EV 02/01/2019 8.40% 50ml 1X25 VL 74104EV 02/01/2019 8.40% 50ml 1X25 VL 74105EV 02/01/2019 8.40% 50ml 1X25 VL 74106EV 02/01/2019 8.40% 50ml 1X25 VL 74107EV 02/01/2019 8.40% 50ml 1X25 VL 74197EV 02/01/2019 8.40% 50ml 1X25 VL 74198EV 02/01/2019 8.40% 50ml 1X25 VL 74199EV 02/01/2019 8.40% 50ml 1X25 VL 74200EV 02/01/2019 8.40% 50ml 1X25 VL 74201EV 02/01/2019 8.40% 50ml 1X25 VL 75171EV 03/01/2019 8.40% 50ml 1X25 VL 75172EV 03/01/2019 8.40% 50ml 1X25 VL 75173EV 03/01/2019 8.40% 50ml 1X25 VL 75174EV 03/01/2019 8.40% 50ml 1X25 VL 75175EV 03/01/2019 8.40% 50ml 1X25 VL 75176EV 03/01/2019 8.40% 50ml 1X25 VL 75177EV 03/01/2019 8.40% 50ml 1X25 VL 75178EV 03/01/2019 8.40% 50ml 1X25 VL 75293EV 03/01/2019 8.40% 50ml 1X25 VL 75418EV 03/01/2019 8.40% 50ml 1X25 VL 75419EV 03/01/2019 8.40% 50ml 1X25 VL

Neut™ Sodium Bicarbonate additive solution 4%

NDC Lot Numbers Expiration Date Strength Configuration/Count 0409-6609-25 75386EV 03/1/2019 4%/5ML 1X25 FTV NOVA PLUS 0409-6609-02 72226EV 12/01/2018 4%/5ML 1X25 FTV 0409-6609-02 72236EV 12/01/2018 4%/5ML 1X25 FTV 0409-6609-02 75382EV 03/01/2019 4%/5ML 1X25 FTV 0409-6609-02 75383EV 03/01/2019 4%/5ML 1X25 FTV

Succinylcholine Chloride Injection, USP/Quelicin®

NDC Lot Numbers Expiration Date Strength Configuration/Count 0409-6629-02 74393EV 05/01/2018 200mg/10ml 1X25 FTV 0409-6629-02 75157EV

75367EV 06/01/2018

06/01/2018 200mg/10ml 1X25 FTV 0409-6629-25 75158EV 06/01/2018 200mg/10ml 1X25 FTV NOVA PLUS 0409-6629-02 75367EV 06/01/2018 200mg/10ml 1X25 FTV

Potassium Phosphates Injection, USP

NDC Lot Numbers Expiration Date Strength Configuration/Count 0409-7295-01 74119EV 02/01/2019 45mM 25X15ML 0409-7295-01 74120EV 02/01/2019 45mM 25X15ML 0409-7295-01 74121EV 02/01/2019 45mM 25X15ML 0409-7295-01 74307EV 02/01/2019 45mM 25X15ML 0409-7295-01 75326EV 03/01/2019 45mM 25X15ML 0409-7295-01 75327EV 03/01/2019 45mM 25X15ML 0409-7295-01 75215EV 03/01/2019 45mM 25X15ML