Data Foundry

Drug recalls 2015

Ketorolac Tromethamine Inj — Class II drug recall D-0973-2015

Terminated recall by Hospira Inc., reported 2015-05-06, distributed nationwide. Crystallization

Recall numberD-0973-2015
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmHospira Inc., Lake Forest, IL, United States
Recall initiated2015-04-13
Classified2015-04-28
Reported by FDA2015-05-06
Terminated2017-12-04
DistributedNationwide (US)
NDC00409-3796-01, 00409-3796-49
Lot numbers38-135-DK, 38-136-DK, 38-137-DK, 44-075-DK, 44-356-DK, 44-357-DK, 44-358-DK, 46-308-DK
Expiration dates2016-02-01, 2016-08-01, 2016-10-01

Product

Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3796-01 --- Also labeled under NOVAPLUS label NDC 00409-3796-49

Reason for recall

Crystallization

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-0973-2015. 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.