Use caution Drug recall · FDA · Published June 7, 2013

Sagent Recalls Vecuronium Bromide Injection Due to Impurity Risks

Sagent Pharmaceuticals recalls Vecuronium Bromide for Injection due to CGMP deviations and failed impurity specifications. Check lot numbers immediately.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-605-2013Drug Sagent Pharmaceuticals ›

Use caution until it’s fixed

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.

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Contact the company

Recalling firmSagent Pharmaceuticals Inc1901 N Roselle Rd Ste 700 · Schaumburg, IL 60195-3194

✎ GovInfoNow plain-language explainer

Sagent Pharmaceuticals is recalling Vecuronium Bromide for Injection because the product was not manufactured under current good manufacturing practices. This deviation led to failed impurity specifications, meaning high levels of out-of-specification impurities were detected in stability samples. The recall affects approximately 831,950 vials distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/47459-sagent-pharmaceuticals-inc-recalls-vecuronium-bromide-for-injection-10-mg.

Source Summary by GovInfoNow · govinfonow.com/recall/47459-sagent-pharmaceuticals-inc-recalls-vecuronium-bromide-for-injection-10-mg · Updated October 13, 2026 · FDA enforcement record: FDA #D-605-2013

Cite this page

“Sagent Recalls Vecuronium Bromide Injection Due to Impurity Risks.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/47459-sagent-pharmaceuticals-inc-recalls-vecuronium-bromide-for-injection-10-mg. Based on FDA recall #D-605-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-605-2013%22&limit=1).

The FDA announced on June 7, 2013, that Sagent Pharmaceuticals Inc voluntarily recalled Vecuronium Bromide for Injection due to current good manufacturing practice deviations. The agency stated the product failed impurity specifications during quality testing.

How to tell if you have it

Brand: Sagent Pharmaceuticals
Product: Vecuronium Bromide Injection
NDC: 25021-657-10
Lot codes: 11F23921A, 11G24001A, 11G24251A, 11G24471A, 11G24701A, 11G25051A, 11G25471A, 11G24341A (Exp 07/13); 11I30521A, 11I31651A, 11I31661A, 11I30481A, 11I30721A, 11I30731A (Exp 09/13); 11I32581A, 11K34241A, 11K34471A, 11K35861A, 11K36761A, 11K37451A, 11K37471A, 11K38171A (Exp 10/13); 11L40161A, 11L40201A, 11L40891A, 11L40781A, 11L40851A, 11L40921A, 11L42961A (Exp 11/13); 11M44271A, 11M44371A, 11M44381A, 11M45041A, 11M45421A, 11M45641A (Exp 12/13); 12A02161A (Exp 01/14); 12B04871A, 12B04921A, 12B06501A, 12B06741A (Exp 02/14); 12C09031A, 12C09041A, 12C09301A, 12C09461A, 12C09471A, 12C11641A (Exp 03/14); 12D12401A, 12D12761A, 12D12861A, 12D13061A, 12D13351A, 12D13361A, 12D13401A (Exp 04/14); 12E15981A (Exp 05/14)
Distribution: Nationwide and Puerto Rico
Units affected: 831,950 vials

The hazard

The FDA said the product was not manufactured under current good manufacturing practices, which contributed to failed impurity specifications. A high out-of-specification impurity result was detected during routine quality testing of stability samples.

Context

GovInfoNow's records show Sagent Pharmaceuticals Inc has 10 other recalls on record since March 4, 2014. Other recent recalls include a May 19, 2023 Nafcillin Injection recall for lack of sterility assurance, a Feb. 28, 2023 Heparin Injection recall for labeling issues, and a March 11, 2021 Phenylephrine HCl Injection recall due to sterility risk. Other recent recalls of similar products include a May 4, 2026 Sagent Busulfan Injection recall for failed impurities, a March 3, 2026 Rising Pharma Temozolomide 5mg Capsules recall due to impurity issues, and a Dec. 30, 2025 Sun Pharmaceutical Fluocinolone Acetonide Solution recall for impurity risk.

How to tell if you have this one

Check if you have Vecuronium Bromide for Injection, 10 mg per vial (1 mg per mL when reconstituted), manufactured by MN Pharmaceuticals. Look for NDC 25021-657-10 and any of the following lot numbers: 11F23921A, 11G24001A, 11G24251A, 11G24471A, 11G24701A, 11G25051A, 11G25471A, 11G24341A (Exp 07/13); 11I30521A, 11I31651A, 11I31661A, 11I30481A, 11I30721A, 11I30731A (Exp 09/13); 11I32581A, 11K34241A, 11K34471A, 11K35861A, 11K36761A, 11K37451A, 11K37471A, 11K38171A (Exp 10/13); 11L40161A, 11L40201A, 11L40891A, 11L40781A, 11L40851A, 11L40921A, 11L42961A (Exp 11/13); 11M44271A, 11M44371A, 11M44381A, 11M45041A, 11M45421A, 11M45641A (Exp 12/13); 12A02161A (Exp 01/14); 12B04871A, 12B04921A, 12B06501A, 12B06741A (Exp 02/14); 12C09031A, 12C09041A, 12C09301A, 12C09461A, 12C09471A, 12C11641A (Exp 03/14); 12D12401A, 12D12761A, 12D12861A, 12D13061A, 12D13351A, 12D13361A, 12D13401A (Exp 04/14); or 12E15981A (Exp 05/14).

Brand
Sagent Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Identify Affected Lots
Check your inventory for Vecuronium Bromide for Injection, NDC 25021-657-10, against the specific lot numbers listed in the recall record.
Contact Manufacturer
Since no specific remedy is stated in the record, contact Sagent Pharmaceuticals directly for instructions on how to handle the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

Jun 7, 2013Firm started the recall
Jun 18, 2013FDA classified it Class II
Jun 26, 2013Published in FDA’s Enforcement Report
May 7, 2015FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/47459-sagent-pharmaceuticals-inc-recalls-vecuronium-bromide-for-injection-10-mg">Sagent Recalls Vecuronium Bromide Injection Due to Impurity Risks (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-605-2013 (June 7, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-605-2013 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.