# FDA recall D-605-2013

> **Sagent Pharmaceuticals Inc** · Class II · drug recall initiated 2013-06-07.

## 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.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-605-2013
- **Recalling firm:** Sagent Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-07
- **Report date:** 2013-06-26
- **Termination date:** 2015-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Schaumburg, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-605-2013

## Citation

> AI Analytics. FDA recall D-605-2013. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-605-2013. Source: US FDA. Licensed CC0.

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