FDA Drug Shortages
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. (Revised 05/15/2020)
| 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) | Experiencing resource constraints and interruption within the supply chain due to the impact of COVID-19. Esimated Availability: late June 2020 | Demand increase for the drug | |
| 200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 16729-432-93), Novaplus | Experiencing resource constraints and interruption within the supply chain due to the impact of COVID-19. Esimated Availability: late June 2020 | Demand increase for the drug |
AuroMedics Pharma LLC (mfd. by Aurobindo Pharma Ltd.) (Revised 05/15/2020)
| 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) | Current backorder estimated to continue through July 2020. | Next shipment expected late June 2020. Intermittent availability expected. | Demand increase for the drug |
Baxter Healthcare (Reverified 05/04/2020)
| 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 |
Fresenius Kabi USA, LLC (Revised 04/21/2020)
| 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 June 2020 | 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) | Backordered. Next release May 2020 | 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) | Backordered. Next release May 2020 | Demand increase for the drug | |
| 200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 63323-421-02) | Backordered. Next release May 2020 | Demand increase for the drug |
Hikma Pharmaceuticals USA, Inc. (formerly West-Ward) (Revised 05/28/2020)
| Presentation | Availability and Estimated Shortage Duration | Related Information | Shortage Reason (per FDASIA) |
|---|---|---|---|
| 100 mcg/mL, 2 mL vial (NDC 0143-9532-25) | This presentation is temporarily on backorder. | Additional lots will be available the middle of May. Product will be made available as it is released. | Demand increase for the drug |
HQ Specialty Pharma (New 04/10/2020)
| 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. Allocating to wholesalers | Distributed by WG Critical Care. Please contact WG Critical Care at 888-493-0861. | Demand increase for the drug |
| 1000 mcg/10 mL (100 mcg/mL), multi-dose vial, box of 4 (NDC 44567-601-04) | Available | Distributed by WG Critical Care. Please contact WG Critical Care at 888-493-0861. | |
| 200 mcg/50 mL (4 mcg/mL), single dose bag, box of 24 (NDC 44567-602-24) | Available. On Allocation | Distributed by WG Critical Care. Please contact WG Critical Care at 888-493-0861. | Demand increase for the drug |
| 400 mcg/100 mL (4 mcg/mL), box of 24 (NDC 44567-603-24) | Available. On Allocation | Distributed by WG Critical Care. Please contact WG Critical Care at 888-493-0861. | Demand increase for the drug |
Jiangsu Hengrui Medicine Co. Ltd. (Reverified 05/11/2020)
| 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) | On allocation | Distributed by Athenex. To order, contact Athenex at 855-273-0154. | Demand increase for the drug |
Mylan Institutional (Reverified 05/01/2020)
| 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) | Intermittent supply | Demand increase for the drug |
Par Pharmaceutical (New 04/10/2020)
| 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 42023-146-25) | Limited supply. Estimated recovery date of late May/early June 2020. | Demand increase for the drug |
Pfizer Pharmaceuticals (Revised 05/20/2020)
| 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) | Limited Supply Available. Weekly Releases. Next Delivery: July 2020; Estimated Recovery: September 2020 | Please check with your wholesaler for available inventory | Demand increase for the drug |
| 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 and Estimated Recovery: May 2020 | Please check with your wholesaler for available inventory | 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) | Limited Supply Available. Weekly Releases. Next Delivery: July 2020; Estimated Recovery: August 2020 | Please check with your wholesaler for available inventory | Demand increase for the drug |
| 200 mcg/2 mL (100 mcg/mL), single dose vial, box of 25 (NDC 0409-1638-02) | Limited Supply Available. Next Delivery: June 2020; Estimated Recovery: July 2020 | Please check with your wholesaler for available inventory
Extended Use Dates Provided by Pfizer to Assist with Emergency Syringe Shortages |
Demand increase for the drug |
Slayback Pharma (Revised 05/18/2020)
| 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 20 (NDC 71225-126-05) | Current backorder estimated to continue until July 2020. | Demand increase for the drug | |
| 400 mcg/100 mL (4 mcg/mL) in 0.9% sodium chloride, single dose bottle, box of 10 (NDC 71225-126-06) | Current backorder estimated to continue until July 2020. | Demand increase for the drug |
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