Reported Nov 27, 2019 · Completed
Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals…
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?
- Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd
- by
Altaire Pharmaceuticals Inc. AquebogueNY 111931NDC 59390-181-13
- Lot codes and dates
1720507/1908/31/20171720607/1909/13/20171727109/1911/08/20171800301/2003/06/20181809704/2005/11/20181816607/2007/26/20181822709/2010/05/20181824610/2011/16/20181831712/2012/18/20181908003/2104/22/20191910604/21
- Amount recalled
- 306,479 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.
Want the full recall guide?
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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