Atracurium Besylate Injection — Class II drug recall D-0398-2015
Terminated recall by Sagent Pharmaceuticals Inc, reported 2015-03-11, distributed nationwide. Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practic
| Recall number | D-0398-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagent Pharmaceuticals Inc, Schaumburg, IL, United States |
| Recall initiated | 2015-02-23 |
| Classified | 2015-03-03 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2016-06-22 |
| Distributed | Nationwide (US) |
| Quantity | 140,720 vials |
| Reason classes | sterility, cgmp |
| NDC | 25021-0659-05 |
| Lot numbers | 08/16, 11/15, VATA012, VATA015 |
Product
Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
Reason for recall
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
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-0398-2015. 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.