Food, drugs, devices › Sagent Pharmaceuticals Inc

Drug recall: VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx

FDA enforcement event 65339 · Class II · initiated 7 Jun 2013 · status Terminated · terminated 7 May 2015

DrugVoluntary: Firm initiated1 product recordSchaumburg, IL

FDA enforcement event 65339 is a drug recall by Sagent Pharmaceuticals Inc of Schaumburg, IL, initiated 7 Jun 2013 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 56% of the 370 drug enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 7 May 2015. Initiation: voluntary: firm initiated. Sagent Pharmaceuticals Inc has 11 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Sagent Pharmaceuticals Inc, Schaumburg, IL.

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"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-605-2013	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.	831,950 vials	Class II	Terminated	26 Jun 2013

Context

56%of 2013 drug events are Class II370 events that year

1product record in this eventfirm median: 1

11events on this register for the firm

Other enforcement events for Sagent Pharmaceuticals Inc

Initiated	Product (first record)	Type	Class	Records
19 May 2023	Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 2502	Drug	Class II	3
28 Feb 2023	Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutan	Drug	Class II	1
11 Mar 2021	Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per ca	Drug	Class II	1
30 Apr 2019	Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceutica	Drug	Class II	1
5 Mar 2018	methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pha	Drug	Class II	3
13 Jun 2016	Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preserva	Drug	Class II	1
1 Mar 2016	Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SA	Drug	Class II	1
23 Feb 2015	Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injec	Drug	Class II	2
3 Oct 2014	Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx	Drug	Class II	1
4 Mar 2014	Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Ster	Drug	Class II	1

All 11 events for Sagent Pharmaceuticals Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide and Puerto Rico"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 7 May 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.