Recalls / Class III
Class IIID-0470-2017
Product
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00
- Brand name
- Pantoprazole Sodium
- Generic name
- Pantoprazole Sodium
- Active ingredient
- Pantoprazole Sodium
- Route
- Intravenous
- NDC
- 55150-202
- FDA application
- ANDA205675
- Affected lot / code info
- Lot #: CPO160028, Exp. June 2018
Why it was recalled
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Ste 210, N/A, Plainsboro, New Jersey 08536-3004
Distribution
- Quantity
- 29800 vials
- Distribution pattern
- Nationwide in US
Timeline
- Recall initiated
- 2016-12-16
- FDA classified
- 2017-02-08
- Posted by FDA
- 2017-02-15
- Terminated
- 2020-07-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0470-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.