D-605-2013 Class II Terminated
FDA drug recall D-605-2013 was initiated by Sagent Pharmaceuticals Inc on Jun 7, 2013 and is designated Class II. 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… The recall status is terminated (terminated May 7, 2015). Affected quantity: 831,950 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 26, 2013
- Initiation Date
- Jun 7, 2013
- Termination Date
- May 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 831,950 vials
Product Description
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 Pattern
Nationwide and Puerto Rico
Code Information
Lot #s: 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-605-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026