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 PharmaceuticalsInc. AllendaleNJ 07401NDC 64980-329-20UPC 364980329200
- Lot codes and dates
Lot#: FR1604BFR1604CFR 1604DExp. 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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