Reported Oct 19, 2016 · Terminated
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution),…
Leiter's Compounding
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: Leiter's Compounding · 17 Great Oaks Blvd · San Jose, CA · 95119-1359
Is this the product you have?
- Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38
- Lot codes and dates
- All unexpired lots; a) Expirations dates of 10/03/2016 to 11/06/2016 and b) 09/25/2016 to 10/01/2016
- Amount recalled
- 76,315 total units, all products
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
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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