Ampicillin Injection, Powder, For Solution
FDA Recall NDC 0781-3402
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ampicillin (NDC 0781-3402). A significant event, classified as Class III, was initiated on Sep 25, 2017 by Sandoz Inc. The reported reason for this action was: "Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels."
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 III Terminated
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Sep 25, 2017
Oct 04, 2017
13,435 shrink wrap packs
Recall Profile & Regulatory Data
Event ID
78169
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sandoz Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Apr 08, 2019
Product Description
Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540.
Batch or Lot Expiration Information
Lot# Lot: GH8254, Exp 06/19
Affected Packages Involved in this Recall
0781-3400-78Product
0781-3400-95Product
0781-3402-78Product
0781-3402-95Product
0781-3407-78Product
0781-3407-95Product
0781-3404-85Product
0781-3404-95Product
0781-3408-80Product
0781-3408-95Product
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.
