AuroMedics Pharma LLC Issued Voluntary Nationwide Recall of Pantoprazole Sodium
AuroMedics Pharma LLC Issued Voluntary Nationwide Recall of Pantoprazole Sodium for
Injection 40 Mg Per Vial, Due to Presence of Glass Particles in the Vial
Reported by Shikha Jain
On 19 December 2017, AuroMedics Pharma LLC has voluntarily recalled one lot (CPO170035,
EXP. May 2019) of Pantoprazole Sodium for Injection 40 mg per vial as a result of presence of
glass particles in the vial. The product has commenced distribution since 7 August 2017. The
issue was highlighted from one of the received market complaint where the contents of one vial
were found to contain a piece of glass.
The intravenous administration of a glass particulate may result in local irritation or swelling or
life-threatening consequences like blockage and clotting in blood vessels. However ,to date, no
any adverse events are attributed to this recall.
The product can be identified as ‘vial stoppered with grey slotted rubber stopper and sealed with
aluminum seals having Sky Blue color polypropylene disc and is packaged in a carton containing
10 vials, NDC: 55150-202- 10.
Consumers/ distributors/ retailers that have the recalled lot should immediately stop using and
return to place of purchase/contact their doctor as appropriate.