Hydromorphone HCl in 0 — Class I drug recall D-1488-2019
Terminated recall by PharMEDium Services, LLC, reported 2019-07-10, distributed nationwide. Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is s
| Recall number | D-1488-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PharMEDium Services, LLC, Dayton, NJ, United States |
| Recall initiated | 2019-06-07 |
| Classified | 2019-07-16 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2020-06-02 |
| Distributed | Nationwide (US) |
| Quantity | 28,140 syringes |
| Reason classes | chemical contamination |
| NDC | 61553-0352-78 |
| Lot numbers | 190670030D, 190670031D, 190670032D, 190670033D, 190710015D, 190710016D, 190710017D, 190710018D, 190710019D, 190730028D, 190730029D, 190730030D, 190740018D, 190770028D, 190770029D, 190780027D, 190780028D, 190780029D, 190790030D, 190800012D, 190800013D, 190800014D, 190800015D, 190800016D, 190810033D, 190810034D, 190810035D, 190810036D, 190840002D, 190870008D, 190910015D, 190980033D, 190990017D, 190990030D, 191000035D, 191010008D, 191010009D, 191010010D, 191050002D, 191120002D and 5 more |
| Expiration dates | 2019-06-09, 2019-06-11, 2019-06-13, 2019-06-16, 2019-06-17, 2019-06-18, 2019-06-19, 2019-06-20, 2019-06-23, 2019-06-24, 2019-06-27, 2019-07-01, 2019-07-08, 2019-07-09, 2019-07-10, 2019-07-11, 2019-07-15, 2019-07-22, 2019-07-28, 2019-07-31, 2019-08-01 |
Product
Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78
Reason for recall
Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
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-1488-2019. 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.