FDA Drug recall D-020-2013
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per ca…
- FDA Drug
- Class I
- terminated
- Published 2012-10-31
On 2012-10-31 the FDA classified a Class I recall of HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per ca… by Hospira, citing superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-020-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-08-15 |
| Published | 2012-10-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit).
Reason
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
Identifiers
| ndc | 0409-2552-11 |
|---|---|
| ndc | 0409-2552-01 |
| ndc | 0409-3356-11 |
| ndc | 0409-3356-01 |
| ndc | 0409-2540-11 |
| ndc | 0409-2540-01 |
| ndc | 0409-3365-11 |
| ndc | 0409-3365-01 |
| ndc | 0409-3365-10 |
| ndc | 0409-1283-03 |
| ndc | 0409-1283-31 |
| ndc | 0409-1312-03 |
| ndc | 0409-1312-30 |
| ndc | 0409-1304-03 |
| ndc | 0409-1304-31 |
| code_info | Lot 12720LL, Exp 12/01/13 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Hospira
- Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest…
FDA Drug · Class I · 2017-05-31 · Hospira - Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to…
FDA Device · Class II · 2017-01-18 · Hospira - 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured…
FDA Drug · Class III · 2016-12-14 · Hospira - Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093…
FDA Drug · Class II · 2016-11-30 · Hospira - Symbiq Two Channel Infuser
FDA Device · Class II · 2016-11-16 · Hospira
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-020-2013%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.