Hydromorphone HCl 0 — Class II drug recall D-0080-2018
Terminated recall by PharMEDium Services, LLC., reported 2017-11-22, distributed in CA, IL. Superpotent drug: out of specification result for potency
| Recall number | D-0080-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PharMEDium Services, LLC., Memphis, TN, United States |
| Recall initiated | 2017-10-13 |
| Classified | 2017-11-14 |
| Reported by FDA | 2017-11-22 |
| Terminated | 2020-01-24 |
| Distributed | CA, IL |
| Quantity | 499 syringes |
| Reason classes | potency, specification failure |
| NDC | 61553-0352-40 |
| Lot numbers | 01/18, 172820134M |
Product
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40
Reason for recall
Superpotent drug: out of specification result for potency
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0080-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.