Current and Resolved Drug Shortages and Discontinuations Reported to FDA
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Dexmedetomidine Hydrochloride Injection
Status: Currently in Shortage
»Date first posted:
04/10/2020
»Therapeutic Categories: Anesthesia
Accord Healthcare Inc. (Revised 11/18/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Injection, 100 ug/1 mL (NDC 16729-239-93) | Unavailable | Resupply TBD | Requirements related to complying with good manufacturing practices |
| Injection, 100 ug/1 mL (NDC 16729-432-93) | Unavailable | Discontinuation of the manufacture of the drug | Discontinuation of the manufacture of the drug |
Amneal Pharmaceuticals (Reverified 11/19/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Injection, 4 mcg/mL, 50 mL (NDC 70121-1388-1) | Available | ||
| Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1) | Available | ||
| Injection, 4 ug/1 mL (NDC 70121-1388-8) | Available | Sufficient Inventory available (6 to 8 wk) as per current demand. | |
| Injection, 4 ug/1 mL (NDC 70121-1389-7) | Available | Sufficient Inventory available (2 to 4 wk) as per current demand. |
Baxter Healthcare (Reverified 10/11/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 0338-9555-24) | Available | ||
| Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 0338-9557-12) | Available | ||
| Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 43066-555-24) | Available | ||
| Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12) | Available |
Eugia US LLC (Reverified 11/18/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Injection, 100 ug/1 mL (NDC 55150-209-02) | Available | Check wholesalers for inventory | |
| Injection, 4 ug/1 mL (NDC 55150-296-10) | Unavailable | On backorder. Recovery: TBD. Check wholesalers for inventory | Demand increase for the drug |
| Injection, 4 ug/1 mL (NDC 55150-297-10) | Available | Check wholesalers for inventory |
Fresenius Kabi USA, LLC (Reverified 11/19/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Injection, 4 ug/1 mL (NDC 63323-671-20) | Unavailable | Not available at this time. | Other |
| Injection, 4 ug/1 mL (NDC 63323-671-50) | Unavailable | Not available at this time. | Delay in shipping of the drug |
| Injection, 4 ug/1 mL (NDC 63323-671-00) | Unavailable | Not available at this time. | Delay in shipping of the drug |
| Injection, 100 ug/1 mL (NDC 63323-421-02) | Unavailable | Backordered. Next release November 2024; Check wholesalers for inventory | Demand increase for the drug |
Gland Pharma Limited (Reverified 10/16/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-976-58) | Available | ||
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 43598-975-58) | Available | ||
| Injection, 200 ug/2 mL (NDC 66794-230-42) | Available | Marketed by Piramal Critical Care Inc.: 800-414-1901 |
Hikma Pharmaceuticals USA, Inc. (Reverified 11/25/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 0143-9532-25) | Unavailable | Shortage duration is unknown at this time. | Demand increase for the drug |
HQ Specialty Pharma (Reverified 05/18/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Injection, 100 ug/1 mL (NDC 44567-600-04) | Available | Marketed by WG Critical Care | |
| Injection, 100 ug/1 mL (NDC 44567-601-04) | Available | Marketed by WG Critical Care | |
| Injection, 4 ug/1 mL (NDC 44567-602-24) | Available | Marketed by WG Critical Care | |
| Injection, 4 ug/1 mL (NDC 44567-603-24) | Available | Marketed by WG Critical Care |
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Revised 07/11/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Injection, 80 mcg/20 mL (NDC 0781-3493-95) | Available | Marketed by Sandoz Inc.; Customer service: 800-525-8747 | |
| Injection, 200 mcg/50 mL (NDC 0781-3494-95) | Available | Marketed by Sandoz Inc.; Customer service: 800-525-8747 | |
| Injection, 400 mcg/100 mL (NDC 0781-3495-95) | Available | Marketed by Sandoz Inc.; Customer service: 800-525-8747 |
Meitheal Pharmaceuticals, Inc. (Revised 11/13/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 71288-505-03) | Available | Estimated recovery end of February 2025 | Demand increase for the drug |
Mylan Institutional, a Viatris Company (Reverified 11/18/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 67457-924-50) | Available | ||
| Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 67457-925-10) | Available | ||
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02) | Available |
Par Pharmaceutical, Inc. (Reverified 11/20/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Injection, 100 ug/1 mL (NDC 42023-146-25) | Available | Please check wholesalers for inventory | |
| Injection, 4 ug/1 mL (NDC 42023-186-20) | Available | Please check wholesalers for inventory | |
| Injection, 4 ug/1 mL (NDC 42023-187-10) | Available | Please check wholesalers for inventory |
Pfizer Inc. (Reverified 11/12/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-3301-10) | Available | ||
| Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-4596-20) | Available | ||
| Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-0155-02) | Available | ||
| Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1174-10) | Available | ||
| Precedex, Injection, 1000 mcg/250 mL Single Dose Glass Bottle (NDC 0409-1434-01) | Available | ||
| Precedex, Injection, 1000 mcg/250 mL Glass Bottle NovaPlus (NDC 0409-2815-01) | Available | ||
| Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1454-20) | Available | ||
| Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-1660-20) | Available | ||
| Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1660-50) | Limited Availability | Next Delivery and Estimated Recovery: December 2024. Shortage per Manufacturer: Manufacturing Delay. | Demand increase for the drug |
| Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1596-10) | Available | ||
| Precedex, Injection, 200 mcg/2 mL (100 mcg/mL) (NDC 0409-1638-02) | Available |
Slayback Pharma (Revised 01/15/2024)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-05) | Available | ||
| Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 71225-126-06) | Available |