7/3/2024

Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection

Products Affected - Description

- Dexmedetomidine hydrochloride solution for injection, Accord, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 16729-0239-93
- Dexmedetomidine hydrochloride solution for injection, Eugia US, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 55150-0209-02
- Dexmedetomidine hydrochloride solution for injection, Hikma, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 00143-9532-25
- Dexmedetomidine hydrochloride solution for injection, Sagent, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 70860-0605-03

Reason for the Shortage

- Accord has dexmedetomidine vials on shortage due to manufacturing issues.
- Eugia did not provide a reason for the shortage.
- Fresenius Kabi has dexmedetomidine vials available.
- Hikma did not provide a reason for the shortage.
- Meitheal has dexmedetomidine vials available.
- Pfizer has Precedex vials available.
- Par has dexmedetomidine vials available.
- Piramal Critical Care has dexmedetomidine vials available.
- Sagent did not provide a reason for the shortage.
- Viatris has dexmedetomidine vials available.
- WG Critical Care has dexmedetomidine vials available.

Available Products

- Precedex solution for injection, Pfizer, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 00409-1638-02
- Dexmedetomidine hydrochloride solution for injection, Fresenius Kabi, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 63323-0421-02
- Dexmedetomidine hydrochloride solution for injection, Meitheal Pharmaceuticals, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 71288-0505-03
- Dexmedetomidine hydrochloride solution for injection, Mylan (Viatris), 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 67457-0251-02
- Dexmedetomidine hydrochloride solution for injection, Par Pharmaceuticals, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 42023-0146-25
- Dexmedetomidine hydrochloride solution for injection, Piramal Critical Care, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 66794-0233-02
- Dexmedetomidine hydrochloride solution for injection, WG Critical Care, 100 mcg/mL, 10 mL single dose vial, 4 count, NDC 44567-0601-04
- Dexmedetomidine hydrochloride solution for injection, WG Critical Care, 100 mcg/mL, 4 mL single dose vial, 4 count, NDC 44567-0600-04

Estimated Resupply Dates

- Accord has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company cannot estimate a release date.
- Eugia has dexmedetomidine 100 mcg/mL 2 mL vials on intermittent back order and the company is releasing supplies as they become available.
- Hikma has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company cannot estimate a release date.
- Sagent has dexmedetomidine 100 mcg/mL 2 mL vials available with short expiration dating (July 2024).

Updated

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