Ceftriaxone for Injection USP — Class I drug recall D-0357-2019
Terminated recall by Lupin Pharmaceuticals Inc., reported 2019-01-16, distributed nationwide. Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber part
| Recall number | D-0357-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2018-12-20 |
| Classified | 2019-01-14 |
| Reported by FDA | 2019-01-16 |
| Terminated | 2020-08-18 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 68180-0633-01, 68180-0633-10 |
Product
Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Reason for recall
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
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-0357-2019. 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.