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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

H J Harkins Company Inc dba Pharma Pac: Gentamicin Ophthalmic Solution Recalled for Crystalline Particulate Matter

Agency Publication Date: January 25, 2019
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Summary

H J Harkins Company Inc is recalling 84 bottles of Gentamicin Opth-Sol (gentamicin sulfate) 5ml ophthalmic solution, a generic version of Garamycin eye drops. The recall was issued because the manufacturer discovered crystalline particles in the solution during quality testing for clarity. These 5-mL plastic dropper bottles were distributed to pharmacies and healthcare facilities nationwide and in Puerto Rico. If you have this medication, you should consult a healthcare professional to determine if your product is safe to use and to find an alternative treatment.

Risk

The presence of crystalline particles in eye drops can cause physical irritation, inflammation, or injury to the delicate tissues of the eye when applied. While no specific injuries have been reported, the contamination represents a significant defect in sterile medication.

What You Should Do

  1. Check your medication to see if you have Gentamicin Opth-Sol 5ml (NDC 52959-0103-00) in a plastic dropper bottle.
  2. Look for lot numbers GNT01AK with an expiration date of 02/19 or lot number GNT07AK with an expiration date of 3/20 on the bottle label.
  3. If your bottle matches these lot numbers or expiration dates, stop using the eye drops immediately.
  4. Contact your doctor or pharmacist to discuss your eye condition and to obtain a safe replacement prescription.
  5. Return any unused portions of the recalled medication to your pharmacy for a refund and contact H J Harkins Company Inc for further instructions regarding disposal or return.
  6. For additional information, you may 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

Return to pharmacy 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: GENTAMICIN OPTH-SOL (5ml)
Model:
NDC 52959-0103-00
AKORN 17478-0283-10
Lot Numbers:
GNT01AK (Exp. 02/19)
Date Ranges: February 2019
Product: GENTAMICIN OPTH-SOL (5ml)
Model:
NDC 52959-0103-00
AKORN 17478-0283-10
Lot Numbers:
GNT07AK (Exp. 3/20)
Date Ranges: March 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81343
Status: Resolved
Manufacturer: H J Harkins Company Inc dba Pharma Pac
Manufactured In: United States
Units Affected: 84, 5 ml bottles
Distributed To: Nationwide
Agency Last Updated: January 28, 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.