Reported Feb 15, 2017 · Terminated
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6…
Aurobindo Pharma USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Aurobindo Pharma USA Inc · 666 Plainsboro Rd Ste 210 · Plainsboro, NJ · 08536-3004
Is this the product you have?
- Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd
- in India for
Auromedics Pharma LLC 6 Wheeling RoadDaytonNJ 08810NDC 55150-202-00
- Lot codes and dates
Lot #: CPO160028Exp. June 2018
- Amount recalled
- 29800 vials
Where it was sold
- Nationwide
Why it was recalled
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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