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
Accord Healthcare Inc. (Reverified 03/05/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Atropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-525-08) | Unavailable | Resupply TBD | Requirements related to complying with good manufacturing practices |
| Atropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-512-43) | Unavailable | Resupply TBD | Requirements related to complying with good manufacturing practices |
| Atropine Sulfate, Injection, 1 mg/1 mL (NDC 16729-526-08) | Unavailable | Resupply TBD | Requirements related to complying with good manufacturing practices |
| Atropine Sulfate, Injection, .05 mg/1 mL (NDC 16729-483-03) | Unavailable | Discontinuation of the manufacture of the drug | Discontinuation of the manufacture of the drug |
| Atropine Sulfate, Injection, .1 mg/1 mL (NDC 16729-484-45) | Unavailable | Resupply TBD | Requirements related to complying with good manufacturing practices |
| Atropine Sulfate, Injection, .1 mg/1 mL (NDC 16729-484-90) | Unavailable | Discontinuation of the manufacture of the drug | Discontinuation of the manufacture of the drug |
American Regent, Inc. (Reverified 02/19/2025)
| 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 02/20/2025)
| 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 03/04/2025)
| 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 |
Hikma Pharmaceuticals USA, Inc. (Reverified 02/14/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Atropine Sulfate, Injection, 0.4 mg/1 mL (NDC 0641-6251-10) | Available |
Hospira, Inc., a Pfizer Company (Reverified 02/26/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Atropine Sulfate, Injection, 1 mg/10 mL (0.1 mg/mL) Syringes (NDC 0409-1630-10) | Available | ||
| Atropine Sulfate, Injection, 0.25 mg/5 mL (0.05 mg/mL) Syringes (NDC 0409-9630-05) | Available | ||
| Atropine Sulfate, Injection, 0.5 mg/5 mL (0.1 mg/mL) Syringes (NDC 0409-4910-34) | Discontinued | Discontinuation of the manufacture of the drug | |
| Atropine Sulfate, Injection, 1 mg/10 mL (0.1 mg/mL) Syringes (NDC 0409-4911-34) | Unavailable | Next Delivery: January 2026; Estimated Recovery: June 2026 | Other |
Medefil, Inc. (Reverified 03/04/2025)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Atropine Sulfate, Injection, .1 mg/1 mL (NDC 64253-400-91) | Available |