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Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Sodium Bicarbonate Injection
Status: Currently in Shortage
»Date first posted: 03/01/2017
»Therapeutic Categories: Endocrinology/Metabolism; Gastroenterology; Pediatric

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Amphastar Pharmaceuticals, Inc./IMS (Reverified 08/12/2022)

Company Contact Information:
800-423-4136

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Sodium Bicarbonate Inj. USP, 8.4%, 50mL Luer-Jet Prefilled Syringe, (NDC 0548-3352-00), (new NDC 76329-3352-1) Backorder due to the increase in demands Demand increase for the drug

Exela Pharma Sciences, LLC (Revised 01/31/2022)

Company Contact Information:
828-758-5474 ext. 154

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
8.4%, 50mL (NDC 51754-5001-05) Available Demand increase for the drug
10 mEq/10 mL (NDC 2551754-5011-04) Currently on backorder
5 mEq/10 mL, 4.2%, (NDC 51754-5012-04) On backorder

Fresenius Kabi USA, LLC (Revised 09/14/2022)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
4.2% Single dose vial, 2.5 mEq per 5 mL (0.5 mEq per mL) (42 mg per mL)(NDC 63323-083-05) Available Check wholesalers for inventory Demand increase for the drug
8.4% Single dose vial, 50 mEq per 50 mL (1 mEq per mL) (84 mg per mL)(NDC 63323-089-50) Backordered. Next release September 2022. Check wholesalers for inventory Demand increase for the drug

Hospira, Inc. (Revised 09/12/2022)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Neut (Sodium Bicarbonate Additive Solution); 200 mg/5 mL (4%); Single Dose Glass Fliptop Vial (NDC 0409-6609-02) Discontinued Discontinuation of the manufacture of the drug
Infant 5 mEq/10 mL (0.5 mEq/mL) ABBOJECT® Glass Syringe (4.2% Concentration) (NDC 0409-5534-14) (old NDC 0409-5534-34) Next Delivery: September 2022; Estimated Recovery: December 2022 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Pfizer Customer Letter dated March 4, 2022.

Other
50 mEq/50 mL (1 mEq/mL) LifeShield® ABBOJECT® Glass Syringe (8.4% Concentration) (NDC 0409-6637-14) (old NDC 0409-6637-34) Next Delivery: September 2022; Estimated Recovery: June 2023 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Pfizer Customer Letter dated March 4, 2022.

Other
2.5 mEq/5 mL (0.5 mEq/mL) Fliptop Vial (4.2% Concentration) (NDC 0409-5555-02) Limited Supply Available. Next Delivery and Estimated Recovery: September 2022 Other
2.5 mEq/5 mL (0.5 mEq/mL) Fliptop Vial Novaplus® (4.2% Concentration) (NDC 0409-5555-01) Available Demand increase for the drug
44.6 mEq/50 mL (0.9 mEq/mL) LifeShield™ ABBOJECT™ Glass Syringe (7.5% concentration) (NDC 0409-4916-14) (old NDC 0409-4916-34) Available

Pfizer Customer Letter dated March 4, 2022.

Other
50 mEq/50 mL (1 mEq/mL) Single Dose Glass Fliptop Vial (8.4% concentration) (NDC 0409-6625-14) (old NDC 0409-6625-02) Limited Supply Available. Next Delivery and Estimated Recovery: September 2022

Dear Customer Letter: Availability Update for Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL)

Other
50 mEq/50 mL (1 mEq/mL) Single Dose Vial Novaplus® (8.4% concentration) (NDC 0409-6625-35) Available Other
Pediatric 10 mEq/10 mL (1 mEq/mL) LifeShield® ABBOJECT® Glass Syringe (8.4% Concentration) (NDC 0409-4900-14) (old NDC 0409-4900-34) Limited Supply Available. Next Delivery: November 2022; Estimated Recovery: December 2022 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Pfizer Customer Letter dated March 4, 2022.

Other
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