FDA recall D-0385-2025

Product

HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.

Reason for recall

Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2025-04-15

Report date

2025-04-30

Termination date

2026-03-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fayetteville, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0385-2025