H J Harkins Company Inc dba Pharma Pac recalls GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Pharma Pac recalls GENTAMICIN OPTH-SOL 5ml (Garamycin) due to crystalline particles found during clarity testing at 24 months. This may cause eye injury if used.
Use caution until it’s fixed
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Contact the company & request your remedy
What happened, in plain English
Pharma Pac is recalling GENTAMICIN OPTH-SOL 5ml eye drops because they found crystalline particles during testing at 24 months. Using these drops could cause eye injury if particles enter the eye. Read more at govinfonow.com/recall/39488-pharma-pac-gentamicin-opth-sol-5ml-particulate-matter-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/39488-pharma-pac-gentamicin-opth-sol-5ml-particulate-matter-hazard · Updated October 5, 2026 · FDA enforcement record: FDA #D-0415-2019
Cite this page
“Pharma Pac GENTAMICIN OPTH-SOL 5ml: Particulate Matter Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39488-pharma-pac-gentamicin-opth-sol-5ml-particulate-matter-hazard. Based on FDA recall #D-0415-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0415-2019%22&limit=1).
Why it’s dangerous
Crystalline particles were detected in the eye drops during 24-month clarity testing. If these particles enter the eye, they could cause irritation or injury.
Who’s affected
People who own or use GENTAMICIN OPTH-SOL 5ml eye drops (Garamycin) from this specific batch. Those with sensitive eyes or who use drops frequently are at higher risk.
How to tell if you have this one
Check for the 5-mL plastic dropper bottle labeled GENTAMICIN OPTH-SOL 5ml (Garamycin). The batch numbers are GNT01AK (expires 02/19) or GNT07AK (expires 03/20).
- Brand
Pharma Pac- Category
Drug
What to do — step by step
Check for Particles
Inspect the eye drops for visible particles before use. If particles are present, do not use.
Questions people ask
Is this product safe to use?
The product may contain particles that could cause eye injury, so it is not safe to use if particles are present.
What should I do if I have this product?
Check for particles. If particles are visible, do not use the drops. Contact Pharma Pac for further instructions.
How can I tell if I have the recalled product?
Look for the 5-mL plastic dropper bottle labeled GENTAMICIN OPTH-SOL 5ml (Garamycin) with batch numbers GNT01AK (expires 02/19) or GNT07AK (expires 03/20).
Contact Pharma Pac
We’ve drafted a message you can send Pharma Pac to request your refund or repair — edit it as you like.
Subject: Recall D-0415-2019 — Pharma Pac Pharma Pac Hello, I own a Pharma Pac that is covered by recall D-0415-2019 from Pharma Pac. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0415-2019 (October 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0415-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.