FDA Drug recall D-0044-2015
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…
- FDA Drug
- Class II
- terminated
- Published 2014-10-29
On 2014-10-29 the FDA classified a Class II recall of 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… by Hospira, citing lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0044-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-01 |
| Published | 2014-10-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
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
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Identifiers
| ndc | 0703-0110-01 |
|---|---|
| ndc | 0703-0110-03 |
| ndc | 0703-0113-01 |
| ndc | 0703-0113-03 |
| ndc | 0703-0018-01 |
| ndc | 0409-2634-10 |
| ndc | 0409-2634-01 |
| ndc | 0409-2634-25 |
| ndc | 0409-2634-05 |
| ndc | 0409-2634-50 |
| code_info | Lot #: a) 260753F, 261403F, Exp 1FEB2015; 290153F, Exp 1MAY2015; b) 24-080-DD, Exp 1DEC2014; 25-475-DD, Exp 1JAN2015 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0044-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.