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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Heritage Pharmaceuticals, Inc.: Amikacin Sulfate and Prochlorperazine Edisylate Injections Recalled for Microbial Growth

Agency Publication Date: June 13, 2019
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Summary

Heritage Pharmaceuticals is recalling approximately 70,440 vials of Amikacin Sulfate Injection and Prochlorperazine Edisylate Injection due to microbial growth found in a sub-lot. These injectable medications, Amikacin Sulfate (an antibiotic) and Prochlorperazine Edisylate (used for severe nausea and vomiting), were found to be non-sterile, which can lead to serious health complications. The products were distributed nationwide in the United States. Consumers who have these medications should stop using them and contact their healthcare provider or pharmacist immediately for guidance and to arrange for a refund.

Risk

Injecting a drug that is not sterile into a patient's bloodstream or muscle can cause severe and potentially life-threatening infections, such as sepsis. The detection of microbial growth in these specific lots indicates a critical failure in the sterilization process, posing a significant risk to patient safety.

What You Should Do

  1. Identify your medication by checking the label for Prochlorperazine Edisylate Injection (10 mg/2mL) or Amikacin Sulfate Injection (1 gram/4 mL).
  2. Check the packaging for specific lot numbers: for Prochlorperazine, look for Lot VPCA172 with an expiration date of April 2020; for Amikacin, look for Lot VEAC025 with an expiration date of October 2019.
  3. Immediately stop using any vials that match these specific lot numbers and expiration dates.
  4. Contact your healthcare provider or pharmacist right away to discuss your treatment and to report any adverse health effects.
  5. Return any unused vials to the pharmacy or place of purchase for a full refund.
  6. Contact Heritage Pharmaceuticals at their East Brunswick office at 1-888-723-3332 for further instructions on how to handle or return the affected products.
  7. For additional questions or to report safety concerns, call the FDA Consumer Complaint hotline at 1-888-463-6332.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider or pharmacist guidance and pharmacy refund.

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

Affected Products

Product: PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial
Model:
NDC 23155-294-31
Lot Numbers:
VPCA172 (Exp April 2020)
Date Ranges: April 2020
Product: AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial
Model:
NDC 23155-290-32
Lot Numbers:
VEAC025 (Exp 10-2019)
Date Ranges: October 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82918
Status: Resolved
Manufacturer: Heritage Pharmaceuticals, Inc.
Sold By: hospitals; pharmacies; healthcare clinics
Manufactured In: India, United States
Units Affected: 2 products (55,480 2 mL vials; 14,960 4 mL vials)
Distributed To: Nationwide
Agency Last Updated: June 19, 2019

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.