Why it was recalled
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: CPO160028, Exp. June 2018
Where it was sold
Nationwide in US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0470-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 16, 2016
- FDA report date
- Feb 15, 2017
- Quantity
- 29800 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc
Original FDA data
Every field from FDA enforcement report D-0470-2017, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75997
- Address
- 666 Plainsboro Rd Ste 210
- Code information
- Lot #: CPO160028, Exp. June 2018
- Postal code
- 08536-3004
- Report date
- Feb 15, 2017
- Product type
- Drugs
- Recall number
- D-0470-2017
- Classification
- Class III
- Recalling firm
- Aurobindo Pharma USA Inc
- Product quantity
- 29800 vials
- Termination date
- Jul 29, 2020
- Reason for recall
- Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in US
- Recall initiation date
- Dec 16, 2016
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2017