Ceftriaxone for Injection USP — Class III drug recall D-0954-2016
Terminated recall by Lupin Pharmaceuticals Inc., reported 2016-06-08, distributed nationwide. CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates fa
| Recall number | D-0954-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2016-03-11 |
| Classified | 2016-06-02 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2017-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 570 vials |
| Reason classes | cgmp, specification failure |
| NDC | 68180-0633-01, 68180-0644-01, 68180-0644-10 |
| Lot numbers | 01/18, C500037 |
Product
Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.
Reason for recall
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
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-0954-2016. 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.