VECURONIUM Bromide for Injection — Class II drug recall D-605-2013
Terminated recall by Sagent Pharmaceuticals Inc, reported 2013-06-26, distributed nationwide. CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to
| Recall number | D-605-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagent Pharmaceuticals Inc, Schaumburg, IL, United States |
| Recall initiated | 2013-06-07 |
| Classified | 2013-06-18 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2015-05-07 |
| Distributed | Nationwide (US) |
| Quantity | 831,950 vials |
| Reason classes | cgmp, specification failure |
| NDC | 25021-0657-10 |
| Lot numbers | 01/14, 02/14, 03/14, 04/14, 05/14, 07/13, 09/13, 10/13, 11/13, 11F23921A, 11G24001A, 11G24251A, 11G24341A, 11G24471A, 11G24701A, 11G25051A, 11G25471A, 11I30481A, 11I30521A, 11I30721A, 11I30731A, 11I31651A, 11I31661A, 11I32581A, 11K34241A, 11K34471A, 11K35861A, 11K36761A, 11K37451A, 11K37471A, 11K38171A, 11L40161A, 11L40201A, 11L40781A, 11L40851A, 11L40891A, 11L40921A, 11L42961A, 11M44271A, 11M44371A and 24 more |
Product
VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.
Reason for recall
CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.
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-605-2013. 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.