Hydromorphone Hydrochloride Injection — Class II drug recall D-0044-2015
Terminated recall by Hospira Inc., reported 2014-10-29, distributed nationwide. Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be bro
| Recall number | D-0044-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-10-01 |
| Classified | 2014-10-23 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2017-03-23 |
| Distributed | Nationwide (US) |
| Quantity | 145,600 vials |
| Reason classes | foreign material, sterility, packaging |
| NDC | 00409-2634, 00409-2634-01, 00409-2634-05, 00409-2634-10, 00409-2634-25, 00409-2634-50, 00703-0018, 00703-0018-01, 00703-0110, 00703-0110-01, 00703-0110-03, 00703-0113, 00703-0113-01, 00703-0113-03 |
| Expiration dates | 2014-12-01, 2015-01-01, 2015-02-01, 2015-05-01 |
Product
Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Forest, IL 60045; Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618; and b) 1 mL Single-dose Vial, packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0409-2634-01), Hospira, Inc., Lake Forest, IL 60045.
Reason for recall
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
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-0044-2015. 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.