FDAFDA · Food and drugs·Recall number D-0385-2025
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.
Published April 30, 2025 · Recall initiated: April 15, 2025
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- OurPharma LLC
- Distributor
- Nationwide in the USA
- Lot
- 104024120001, Exp Date 06/01/2025; 104024120002, Exp Date 06/21/2025; 104025010001, Exp Date 07/13/2025; 104025010002, Exp Date 07/28/2025
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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