FDAHealthApril 15, 2025
OurPharma LLC — 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.
⚠️ Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 15, 2025
Nationwide in the USA
What's affected?
- 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.
- Brand
- OurPharma LLC
- Lot code
- 104024120001, Exp Date 06/01/2025; 104024120002, Exp Date 06/21/2025; 104025010001, Exp Date 07/13/2025; 104025010002, Exp Date 07/28/2025
Additional details
104024120001, Exp Date 06/01/2025; 104024120002, Exp Date 06/21/2025; 104025010001, Exp Date 07/13/2025; 104025010002, Exp Date 07/28/2025
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 1,375 cassettes.
Get Health recall alerts
Delivered to your inbox. Free. No account required.