Pantoprazole Sodium Injection, Powder, For Solution
FDA Recall NDC 55150-202
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Pantoprazole Sodium (NDC 55150-202). A significant event, classified as Class I, was initiated on Dec 04, 2017 by Eugia Us Llc. The reported reason for this action was: "Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Dec 04, 2017
Feb 14, 2018
66,100 vials
Recall Profile & Regulatory Data
Event ID
78696
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide in the USA
Termination Date
Mar 17, 2020
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
Batch or Lot Expiration Information
Lot# CPO170035
Affected Packages Involved in this Recall
55150-202-00Product
55150-202-10Product
55150-202-25Product
Class III Terminated
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Dec 16, 2016
Feb 15, 2017
29800 vials
Recall Profile & Regulatory Data
Event ID
75997
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in US
Termination Date
Jul 29, 2020
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
Batch or Lot Expiration Information
Lot# : CPO160028, Exp. June 2018
Affected Packages Involved in this Recall
55150-202-00Product
55150-202-10Product
55150-202-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
