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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Schering Corp: Lack of assurance of sterility

Agency Publication Date: December 7, 2002
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Summary

Schering Corp is recalling 587 units of Trilafon Injection, USP (perphenazine) 5 mg/1 mL ampules because of a lack of assurance of sterility. This prescription medication is used as an antipsychotic, and the recall affects product sold through direct accounts, Pharmacia, and Serono Laboratories. While no incidents or injuries have been reported to date, the lack of sterility in an injectable product can lead to serious health complications for patients.

Risk

A lack of sterility in an injectable drug means the product may be contaminated with microorganisms. Injecting a non-sterile medication directly into the body can cause severe infections, abscesses, or life-threatening systemic illness.

What You Should Do

  1. Check your medical supplies for Trilafon Injection, USP (Perphenazine), 5 mg, 1 mL Ampules with NDC-0085-0012-04 and Recall Number D-072-3.
  2. If you identify this product, immediately stop using it and do not administer the injection.
  3. Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report the affected product.
  4. Return any unused ampules to the pharmacy or the place of purchase for a refund.
  5. Contact the manufacturer, Schering Corp, for further instructions regarding the return or disposal of the affected medication.
  6. 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

๐Ÿ’ฐFull Refund

Contact healthcare provider and return for refund

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

Affected Products

Product: Trilafon Injection, USP (Perphenazine), 5 mg (1 mL Ampule)
Model:
NDC-0085-0012-04
Recall #: D-072-3

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 25048
Status: Active
Manufacturer: Schering Corp
Manufactured In: United States
Units Affected: 6 products (47,016; 61,608; 23,538; 587; 3,620,480; 294,477)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 ยท 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.