Reported May 2, 2018 · Terminated

Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc.…

Lyne Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lyne Laboratories, Inc. · 10 Burke Dr · Brockton, MA · 02301-5505

Is this the product you have?

  • Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only
  • Manufactured byLyne Laboratories, Inc. Brockton
  • MA 02307 Manufactured for
    • Rising Pharmaceuticals
    • Inc. Allendale
    • NJ 07401
    • NDC 64980-329-20
    • UPC 364980329200
Lot codes and dates
    • Lot#: FR1604B
    • FR1604C
    • FR 1604D
    • Exp. 06/2018
Amount recalled
17939 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Why it was recalled

Subpotent Drug

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 16, 2019 · Data as of Sep 19, 7:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.