3/6/2025

Methadone Hydrochloride Oral Solution

Products Affected - Description

- Methadone hydrochloride Intensol oral solution, Hikma, 10 mg/mL concentrate, 30 mL bottle, unflavored, NDC 00054-3553-44
- Methadone hydrochloride oral solution, Hikma, 10 mg/mL concentrate, 1000 mL bottle, cherry flavor, NDC 00054-0392-68
- Methadone hydrochloride oral solution, Hikma, 10 mg/mL concentrate, 1000 mL bottle, unflavored, NDC 00054-0391-68
- Methadone hydrochloride oral solution, Hikma, 5 mg/5 mL, 500 mL bottle, NDC 00054-3555-63

Reason for the Shortage

- Hikma did not provide a reason for the shortage.
- Mallinckrodt refuses to provide availability information.

Available Products

- Methadone hydrochloride oral solution, Hikma, 10 mg/5 mL, 500 mL bottle, NDC 00054-3556-63

Estimated Resupply Dates

- Hikma has methadone 5 mg/5 mL oral solution in 500 mL bottles on back order and the company estimates a release date of late-May 2025. The 10 mg/mL concentrated solution in 1,000 mL bottles (cherry flavor and unflavored) is on allocation. Methadone Intensol 10 mg/mL concentrated solution in 30 mL bottles is also on allocation.

Updated

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