Reported Oct 4, 2017 · Terminated

Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs…

Sandoz Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sandoz Inc · 100 College Rd W · Princeton, NJ · 08540-6604

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot
    • GH8254
    • Exp 06/19
Amount recalled
13,435 shrink wrap packs

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 8, 2019 · Data as of Sep 19, 7:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.