Preferred Pharmaceuticals Ophthalmic Ointment Recall: Manufacturing Quality Issues
Preferred Pharmaceuticals recalls Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg ophthalmic ointment due to insufficient quality assurance controls in manufacturing. This product is available in specific lot numbers and expiration dates.
Recall notice
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Contact the company
What happened, in plain English
Preferred Pharmaceuticals is recalling a specific ophthalmic ointment product due to manufacturing quality control issues. This recall affects certain lot numbers and expiration dates of the product, which may not meet safety standards. Read more at govinfonow.com/recall/38264-preferred-pharmaceuticals-ophthalmic-ointment-recall-manufacturing-quality-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/38264-preferred-pharmaceuticals-ophthalmic-ointment-recall-manufacturing-quality-issues · Updated October 5, 2026 · FDA enforcement record: FDA #D-1491-2019
Cite this page
“Preferred Pharmaceuticals Ophthalmic Ointment Recall: Manufacturing Quality Issues.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38264-preferred-pharmaceuticals-ophthalmic-ointment-recall-manufacturing-quality-issues. Based on FDA recall #D-1491-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1491-2019%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. This means the ointment may not meet the required safety and effectiveness standards.
Who’s affected
People who have purchased this ophthalmic ointment from specific lot numbers and expiration dates are affected. Those using the product for eye conditions are at risk if they have the recalled batch.
How to tell if you have this one
Check the product label for the lot number and expiration date. The recalled ointment has specific lot numbers: L2117Q, F2818H, and B1819T001 to B1819T048, with expiration dates up to May 2020.
- Brand
Preferred Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Label
Look for the lot number and expiration date on the ointment tube to determine if it is part of the recalled batch.
Where it went and when
Where it was distributed
Distributed in California and Florida.
FDA distribution: “CA, FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida.
Recall timeline
FDA terminated this recall 3.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1491-2019 (July 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1491-2019 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.