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

FDA recall notice · announced February 15, 2017 · Aurobindo Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.

Notes

Distribution: Nationwide in US
Lot/code information: Lot #: CPO160028, Exp. June 2018
Quantity: 29800 vials
Status: Terminated
Products in this recall event:
- 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 (D-0470-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.