FDA Drug recall D-0470-2017
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayt…
- FDA Drug
- Class III
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class III recall of Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayt… by Aurobindo Pharma Usa, citing discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0470-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-12-16 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
Product
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00
Reason
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Identifiers
| ndc | 55150-202-00 |
|---|---|
| ndc | 55150-202-10 |
| ndc | 55150-202-25 |
| code_info | Lot #: CPO160028, Exp. June 2018 |
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-0470-2017%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.