Recalls / Class I
Class ID-0340-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- 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 # CPO170035
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
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 66,100 vials
- Distribution pattern
- Product was distributed nationwide in the USA
Timeline
- Recall initiated
- 2017-12-04
- FDA classified
- 2018-02-08
- Posted by FDA
- 2018-02-14
- Terminated
- 2020-03-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0340-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.