[pending] HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LL
Pending LLM rewrite. Source: FDA_DRUG D-0385-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
The recalled product
- 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.
- Manufacturer
- OurPharma LLC
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
Distributed nationwide across the United States.
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