H J Harkins Company Inc dba Pharma Pac recalls Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only,
Pharma Pac recalls Neomycin 3.5 mg/g ophthalmic ointment due to insufficient quality assurance controls in manufacturing. This product was sold with specific lot numbers and expiration dates.
Recall notice
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Contact the company & request your remedy
What happened, in plain English
Pharma Pac is recalling a specific ophthalmic ointment product due to manufacturing quality control issues. This recall affects prescription-only ointments with certain lot numbers and expiration dates. Read more at govinfonow.com/recall/38322-pharma-pac-ophthalmic-ointment-recall-manufacturing-quality-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/38322-pharma-pac-ophthalmic-ointment-recall-manufacturing-quality-issues · Updated October 5, 2026 · FDA enforcement record: FDA #D-1580-2019
Cite this page
“Pharma Pac Ophthalmic Ointment Recall: Manufacturing Quality Issues.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38322-pharma-pac-ophthalmic-ointment-recall-manufacturing-quality-issues. Based on FDA recall #D-1580-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1580-2019%22&limit=1).
Why it’s dangerous
The recall is due to insufficient quality assurance controls during manufacturing, which could lead to potential quality issues with the product. However, the specific risk to patients is not clearly described in the recall notice.
Who’s affected
Prescription patients who received this ointment with the listed lot numbers and expiration dates. Those using the product without a prescription are not affected.
How to tell if you have this one
Check the product label for the lot numbers NPD10RP through NPD18RP and expiration dates from August 2019 to February 2021. This ophthalmic ointment is prescription-only and sold under the brand name Pharma Pac.
- Brand
Pharma Pac- Category
Drug
What to do — step by step
Check Product Label
Look for lot numbers NPD10RP through NPD18RP and expiration dates from August 2019 to February 2021 on the ointment tube.
Questions people ask
Is this ointment safe to use?
The recall states there were manufacturing quality control issues, but does not specify if the product is safe to use. Patients should check the product label for the affected lot numbers and contact their healthcare provider.
What should I do if I have this ointment?
The recall does not provide a specific remedy, so you should check the product label for the affected lot numbers and contact your healthcare provider for guidance.
Is this ointment available over the counter?
No, this ointment is prescription-only as stated in the recall.
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-1580-2019 — Pharma Pac Pharma Pac Hello, I own a Pharma Pac that is covered by recall D-1580-2019 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-1580-2019 (July 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1580-2019 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.