Reported Nov 27, 2019 · Completed
OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX…
Altaire Pharmaceuticals, 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: Altaire Pharmaceuticals, Inc. · 311 W Ln · Aquebogue, NY · 11931-0849
Is this the product you have?
- OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05
- Lot codes and dates
171866/201734511/20190101/22170412/2020162178/19
- Amount recalled
- 81403 units
This recall covers 134 products
The agency filed one notice per product. You are reading one of them; the other 133 are below.
121 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
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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