Recall D-0385-2025

US Class III Terminated · initiated 2025-04-15

Recalling firm

OurPharma LLC, AR

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..

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