D-0385-2025 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2025
- Initiation Date
- April 15, 2025
- Termination Date
- March 6, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,375 cassettes
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..
Distribution Pattern
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