Why it was recalled
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Product description
Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00
Lot numbers, UPCs & expiration codes
Lot # CPO170035
Where it was sold
Product was distributed nationwide in the USA
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-0340-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 4, 2017
- FDA report date
- Feb 14, 2018
- Quantity
- 66,100 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0340-2018, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78696
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot # CPO170035
- Postal code
- 08520-1401
- Report date
- Feb 14, 2018
- Product type
- Drugs
- Recall number
- D-0340-2018
- Classification
- Class I
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 66,100 vials
- Termination date
- Mar 17, 2020
- Reason for recall
- Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00
- Distribution pattern
- Product was distributed nationwide in the USA
- Recall initiation date
- Dec 4, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2018