HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma,...
FDA Recall #D-0385-2025 — Class III — April 15, 2025
Product Description
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..
Recalling Firm
OurPharma LLC — Fayetteville, AR
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1,375 cassettes
Distribution
Nationwide in the USA
Code Information
104024120001, Exp Date 06/01/2025; 104024120002, Exp Date 06/21/2025; 104025010001, Exp Date 07/13/2025; 104025010002, Exp Date 07/28/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated