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FDA Drug Shortages

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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: No date available
»Therapeutic Categories: Anesthesia; Neurology; Pediatric

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Accord Healthcare Inc. (Revised 04/18/2023)

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

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-525-08) Available Demand increase for the drug
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-512-43) Available Demand increase for the drug
Atropine Sulfate, Injection, 1 mg/1 mL (NDC 16729-526-08) Available Demand increase for the drug
Atropine Sulfate, Injection, .05 mg/1 mL (NDC 16729-483-03) Available
Atropine Sulfate, Injection, .1 mg/1 mL (NDC 16729-484-45) Inventory on hold pending further assessment Inventory on hold pending further assessment
Atropine Sulfate, Injection, .1 mg/1 mL (NDC 16729-484-90) Available

American Regent, Inc. (Revised 09/07/2023)

Company Contact Information:
800-645-1706

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

Amphastar Pharmaceuticals, Inc. (Revised 09/07/2023)

Company Contact Information:
800-423-4136

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

Fresenius Kabi USA, LLC (Reverified 09/01/2023)

Company Contact Information:
888-386-1300

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

Hikma Pharmaceuticals USA, Inc. (Revised 05/18/2023)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 0641-6251-10) Inventory is currently available. Additional lots are scheduled for manufacturing. Product will be made available as it is released.

Hospira, Inc. (Revised 09/11/2023)

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) Depleted Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter: Emergency Syringe Availability Update

Regulatory delay
Atropine Sulfate, Injection, .05 mg/1 mL (NDC 0409-9630-05) Available

Dear Customer Letter: Emergency Syringe Availability Update

Demand increase for the drug
Atropine Sulfate, Injection, .1 mg/1 mL (NDC 0409-4910-34) Limited Supply Available. 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)

Demand increase for the drug
Atropine Sulfate, Injection, .1 mg/1 mL (NDC 0409-4911-34) Depleted Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter: Emergency Syringe Availability Update

Demand increase for the drug
Injection, 0.1 mg/mL, 10 mL (NDC 0409-4911-11) Next Delivery: August 2023; Estimated Recovery: December 2023 Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay

Dear Customer Letter: Emergency Syringe Availability Update

Medefil, Inc. (New 06/15/2023)

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 Demand increase for the drug
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