FDA Drug recall D-0027-2015
Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAG…
- FDA Drug
- Class II
- terminated
- Published 2014-10-22
On 2014-10-22 the FDA classified a Class II recall of Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAG… by Sagent Pharmaceuticals, citing incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0027-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-03 |
| Published | 2014-10-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sagent Pharmaceuticals |
| Distribution | US |
Product
Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195
Reason
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
Identifiers
| ndc | 25021-700-01 |
|---|---|
| ndc | 25021-701-01 |
| ndc | 25021-701-02 |
| code_info | Lot MP5021, Exp. 04/16; Lots MP5024, MP5025, Exp. 05/16 |
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-0027-2015%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.