Drug 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.
D-0385-2025
Product summary
- Firm
- OurPharma LLC
- Event
- Event 96706
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,375 cassettes
- Official record key
drug-enforcement:D-0385-2025
Official wording
Reason: Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
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
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Superpotent