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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sandoz Inc: Ampicillin for Injection Recalled Due to Missing Vial Labels

Agency Publication Date: September 28, 2017
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Summary

Sandoz Inc has recalled approximately 13,435 shrink wrap packs of the antibiotic Ampicillin for Injection, USP (500 mg per vial). The recall was initiated after a customer reported that individual vials within the 10-count shrink wrap packs were missing their identifying labels. This medication is used to treat various bacterial infections, and the absence of a label can lead to significant confusion or the use of the wrong medication in clinical settings. The affected packs were distributed nationwide across the United States and Puerto Rico.

Risk

If a vial is missing its label, healthcare providers cannot verify the name of the drug, its strength, or its expiration date. This creates a risk of medication errors, where a patient might receive the wrong drug or an incorrect dose, potentially leading to ineffective treatment or adverse reactions.

What You Should Do

  1. Identify the product: Look for Ampicillin for Injection, USP, 500 mg per vial, packaged in 10-count shrink wrap packs.
  2. Check the packaging for NDC numbers: NDC 0781-3407-78 (found on individual vials) or NDC 0781-3407-95 (found on the 10-count shrink wrap pack).
  3. Check the lot number and expiration date: Only lot GH8254 with an expiration date of June 2019 (Exp 06/19) is included in this recall.
  4. If you identify any vials that are missing labels, do not use the medication and secure the product immediately.
  5. Contact your healthcare provider or pharmacist for guidance regarding replacement medication. Return any unused product to the pharmacy for a refund.
  6. For further instructions, contact Sandoz Inc at their Princeton office located at 100 College Rd W, Princeton, New Jersey, 08540-6604.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Refund and guidance from healthcare professionals.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Ampicillin for Injection, USP, 500 mg per vial (10-count shrink wrap packs)
Model:
NDC 0781-3407-78
NDC 0781-3407-95
Lot Numbers:
GH8254 (Exp 06/19)
Date Ranges: Exp 06/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78169
Status: Resolved
Manufacturer: Sandoz Inc
Sold By: Pharmacies; Hospitals; Healthcare Providers
Manufactured In: Austria, United States
Units Affected: 13,435 shrink wrap packs
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.