WhichRecall
Class IIIReported 2025-04-30

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.

Recalled by OurPharma LLC

Reason for Recall

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

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Recall Number
D-0385-2025
Classification
Class III
Status
Terminated
Category
drug
Initiated
2025-04-15
Reported
2025-04-30
Distribution
Nationwide in the USA
Code Info
104024120001, Exp Date 06/01/2025; 104024120002, Exp Date 06/21/2025; 104025010001, Exp Date 07/13/2025; 104025010002, Exp Date 07/28/2025
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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