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Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Atropine Sulfate Injection
Status: Currently in Shortage
»Date first posted: 01/01/2012
»Therapeutic Categories: Anesthesia; Neurology; Pediatric

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Accord Healthcare Inc. (Revised 02/05/2024)

Company Contact Information:
866-941-7875, option 2

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Injection, .4 mg/1 mL (NDC 16729-525-08) Unavailable, Timelines not Available at this time Shortage duration not available. Requirements related to complying with good manufacturing practices
Injection, .4 mg/1 mL (NDC 16729-512-43) Unavailable, Timelines not Available at this time Shortage duration not available. Requirements related to complying with good manufacturing practices
Injection, 1 mg/1 mL (NDC 16729-526-08) Unavailable, Timelines not Available at this time Shortage duration not available. Requirements related to complying with good manufacturing practices
Injection, .05 mg/1 mL (NDC 16729-483-03) Unavailable, Timelines not Available at this time Shortage duration not available. Requirements related to complying with good manufacturing practices
Injection, .1 mg/1 mL (NDC 16729-484-45) Inventory on hold pending further assessment, Timelines not Available at this time Inventory on hold pending further assessment Requirements related to complying with good manufacturing practices
Injection, .1 mg/1 mL (NDC 16729-484-90) Unavailable, Timelines not Available at this time Shortage duration not available. Requirements related to complying with good manufacturing practices

American Regent, Inc. (Reverified 02/01/2024)

Company Contact Information:
800-645-1706

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Injection, 1 mg/1 mL (NDC 0517-1001-25) Available old NDC 0517-1010-25
Injection, .4 mg/1 mL (NDC 0517-1004-25) Available old NDC 0517-0401-25

Amphastar Pharmaceuticals, Inc. (Reverified 02/08/2024)

Company Contact Information:
800-423-4136

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Injection, .1 mg/1 mL (NDC 76329-3340-1) Available

Fresenius Kabi USA, LLC (Reverified 02/01/2024)

Company Contact Information:
888-386-1300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Injection, .4 mg/1 mL (NDC 63323-580-20) Available Check wholesalers for inventory

Hikma Pharmaceuticals USA, Inc. (Revised 02/22/2024)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Atropine Sulfate Injection, USP, Injection, 0.4 mg/1 mL (NDC 0641-6251-10) Available Additional lots are scheduled for manufacturing. Product will be made available as it is released.

Hospira, Inc., a Pfizer Company (Revised 02/27/2024)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Atropine Sulfate, Injection, .1 mg/1 mL (NDC 0409-1630-10) Unavailable, 3Q 2024 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter: Emergency Syringe Availability Update

Delay in shipping of the drug
Atropine Sulfate, Injection, .05 mg/1 mL (NDC 0409-9630-05) Available

Dear Customer Letter: Emergency Syringe Availability Update

Atropine Sulfate, Injection, .1 mg/1 mL (NDC 0409-4910-34) Limited Availability, 4Q 2024 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter: Inventory Management Update for Pfizer Hospital Rocky Mount Products dated 8-24-2023 (hyperlink)

Delay in shipping of the drug
Atropine Sulfate, Injection, .1 mg/1 mL (NDC 0409-4911-34) Unavailable, 4Q 2024 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter: Emergency Syringe Availability Update

Delay in shipping of the drug
Injection, 0.1 mg/mL, 10 mL (NDC 0409-4911-11) Unavailable Next Delivery: June 2024; Estimated Recovery: TBD

Dear Customer Letter: Emergency Syringe Availability Update

Delay in shipping of the drug

Medefil, Inc. (Revised 01/15/2024)

Company Contact Information:
630-682-4600

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Atropine Sulfate, Injection, .1 mg/1 mL (NDC 64253-400-91) Available
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