Reported Jun 26, 2013 · Terminated
VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx…
Sagent Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sagent Pharmaceuticals Inc · 1901 N Roselle Rd Ste 700 · Schaumburg, IL · 60195-3194
Is this the product you have?
- 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.
- Lot codes and dates
64 of 64 codes
Lot #s: 11F23921A11G24001A11G24251A11G24471A11G24701A11G25051A11G25471A11G24341AExp 07/1311I30521A11I31651A11I31661A11I30481A11I30721A11I30731AExp 09/1311I32581A11K34241A11K34471A11K35861A11K36761A11K37451A11K37471A11K38171AExp 10/1311L40161A11L40201A11L40891A11L40781A11L40851A11L40921A11L42961AExp 11/1311M44271A11M44371A11M44381A11M45041A11M45421A11M45641AExp 12/1312A02161AExp 01/1412B04871A12B04921A12B06501A12B06741AExp 02/1412C09031A12C09041A12C09301A12C09461A12C09471A12C11641AExp 03/1412D12401A12D12761A12D12861A12D13061A12D13351A12D13361A
- Amount recalled
- 831,950 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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