Hydromorphone HCl 1 mg/mL PF INJ — Class II drug recall D-0701-2018
Terminated recall by Premier Pharmacy Labs Inc, reported 2018-05-02, distributed nationwide. Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unrel
| Recall number | D-0701-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Premier Pharmacy Labs Inc, Weeki Wachee, FL, United States |
| Recall initiated | 2018-04-11 |
| Classified | 2018-04-26 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2020-09-15 |
| Distributed | Nationwide (US) |
| Quantity | 3,570 syringes |
| Reason classes | microbial contamination, sterility |
| NDC | 69623-0249-10 |
| Lot numbers | HYD030118IJDSA, HYD030118IJDSB, HYD030118IJDSD, HYD030118IJDSE |
| Expiration dates | 2018-05-30 |
Product
Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10
Reason for recall
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
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-0701-2018. 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.