Current and Resolved Drug Shortages and Discontinuations Reported to FDA
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Dexmedetomidine Injection
Status: Currently in Shortage
»Date first posted:
04/10/2020
»Therapeutic Categories: Anesthesia
Accord Healthcare Inc. (Reverified 04/21/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 16729-239-93) | Available | ||
| 200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 16729-432-93), Novaplus | Available |
Amneal Pharmaceutical (Reverified 04/07/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 200 mcg/50 mL (4 mcg/mL) in 0.9% sodium chloride, single-dose bottle (NDC 70121-1388-8 box of 20; NDC 70121-1388-1 individual) | Available | ||
| 400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single-dose bottle (NDC 70121-1389-7 box of 10; NDC 70121-1389-1 individual) | Available |
Baxter Healthcare (Reverified 08/26/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 200 mcg/50 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bag, box of 24 (NDC 0338-9555-24) | Available | ||
| 400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bag, box of 12 (NDC 0338-9557-12) | Available | ||
| 200 mcg/50 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bag, box of 24 (NDC 43066-555-24), Novaplus | Available | ||
| 400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bag, box of 12 (NDC 43066-557-12), Novaplus | Available |
Eugia Pharma Specialties LTD. (formerly Aurobindo) (Reverified 08/12/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 55150-209-02) | Available | Demand increase for the drug | |
| 200mcg/50mL, single dose bag (NDC 55150-296-10) | Available | Demand increase for the drug | |
| 400mcg/100mL, single dose bag (NDC 55150-297-10) | Available | Demand increase for the drug |
Fresenius Kabi USA, LLC (Reverified 09/14/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 80 mcg/20 mL (4 mcg/mL) in 0.9% sodium chloride, single dose vial, box of 10 (NDC 63323-671-20) | Backordered. Next release September 2022. | Demand increase for the drug | |
| 200 mcg/50 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 25 (NDC 63323-671-50) | Available | Demand increase for the drug | |
| 400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 10 (NDC 63323-671-00) | Available | Demand increase for the drug | |
| 200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 63323-421-02) | Available | Demand increase for the drug |
Gland Pharma Limited (Reverified 08/12/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 200 mcg/50 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 10 (NDC 43598-976-58) | Inventory available | ||
| 400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 10 (NDC 43598-975-58) | Inventory available |
Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Reverified 04/08/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 100 mcg/mL, 2 mL vial (NDC 0143-9532-25) | Inventory is currently available | Demand increase for the drug |
Hong Kong King Friend Industrial Co. Ltd. (Reverified 04/07/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 200 mcg/2 mL (100 mcg/mL) single dose vial, box of 25 (NDC 71288-505-03) | Available |
HQ Specialty Pharma (Reverified 09/12/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 400 mcg/4 mL (100 mcg/mL), multi-dose vial, box of 4 (NDC 44567-600-04) | Available | Demand increase for the drug | |
| 1000 mcg/10 mL (100 mcg/mL), multi-dose vial, box of 4 (NDC 44567-601-04) | Available | Demand increase for the drug | |
| 200 mcg/50 mL (4 mcg/mL), single dose bag, box of 24 (NDC 44567-602-24) | Available | Demand increase for the drug | |
| 400 mcg/100 mL (4 mcg/mL), box of 24 (NDC 44567-603-24) | Available | Demand increase for the drug |
Jiangsu Hengrui Medicine Co. Ltd. (Reverified 09/12/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 70860-605-03) | Available | Demand increase for the drug |
Mylan Institutional, a Viatris company (Reverified 09/13/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 67457-251-02) | Available | Short dated stock (4/2022 expiry) available by request. Additional manufacturer in progress. | Demand increase for the drug |
| 0.2 mg / 50 ml (Solution in Single Use Vials/Bottles), 20PK (NDC 67457-924-50) | Available | Demand increase for the drug | |
| 0.4 mg / 100 ml (Solution in Single Use Vials/Bottles), 10PK (NDC 67457-925-10) | Available | Demand increase for the drug |
Par Pharmaceutical (Reverified 09/21/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 200 mcg/50 mL (4 mcg/mL), 50 mL single dose vial, box of 25 (NDC 42023-186-20) | Par Product Available – Please Check Wholesalers | ||
| 400 mcg/100 mL (4 mcg/mL), 100 mL single dose vial, box of 10 (NDC 42023-187-10) | Par Product Available – Please Check Wholesalers | ||
| 100 mcg/mL, 2 mL single dose vial, box of 25 (NDC 42023-146-25) | Par Product Available – Please Check Wholesalers |
Pfizer Pharmaceuticals (Revised 09/12/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 80 mcg/20 mL (4 mcg/mL) in 0.9% sodium chloride, single dose vial, box of 10 (NDC 0409-1660-20) | Depleted. Next Delivery and Estimated Recovery: October 2022 | Check Wholesaler for Availability Shortage per Manufacturer: Manufacturing Delay | Other |
| 200 mcg/50 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 20 (NDC 0409-1660-50) | Limited Supply Available. Next Delivery: September 2022; Estimated Recovery: January 2023 | Demand increase for the drug | |
| 400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 10 (NDC 0409-1660-10) | Available | Other | |
| 200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 0409-1638-02) | Available |
Search List of Extended Use Dates to Assist with Drug Shortages |
Other |
Slayback Pharma (Revised 06/01/2022)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 4 mcg/mL in 0.9% sodium chloride, 50 mL single dose bottle, box of 20 (NDC 71225-126-05) | Available | ||
| 4 mcg/mL in 0.9% sodium chloride, 100 mL single dose bottle, box of 10 (NDC 71225-126-06) | Available |