FDA Drug recall D-0388-2015
Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc.,…
- FDA Drug
- Class II
- terminated
- Published 2015-02-25
On 2015-02-25 the FDA classified a Class II recall of Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc.,… by Hospira, citing temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0388-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-06 |
| Published | 2015-02-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01.
Reason
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Identifiers
| ndc | 0409-3793-19 |
|---|---|
| ndc | 0409-3793-01 |
| ndc | 0409-3793-25 |
| ndc | 0409-3795-19 |
| ndc | 0409-3795-01 |
| ndc | 0409-3795-25 |
| ndc | 0409-3796-19 |
| ndc | 0409-3796-01 |
| ndc | 0409-3796-25 |
| code_info | One shipment of Lot #: 34-540-DK; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI |
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-0388-2015%22
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