Pantoprazole Sodium for Injection — Class I drug recall D-0340-2018
Terminated recall by AuroMedics Pharma LLC, reported 2018-02-14, distributed nationwide. Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a p
| Recall number | D-0340-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2017-12-04 |
| Classified | 2018-02-08 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2020-03-17 |
| Distributed | Nationwide (US) |
| Quantity | 66,100 vials |
| Reason classes | foreign material, specification failure |
| NDC | 55150-0202, 55150-0202-00, 55150-0202-10, 55150-0202-25 |
| Lot numbers | CPO170035 |
Product
Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00
Reason for recall
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
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-0340-2018. 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.