Reported Sep 23, 2015 · Terminated
Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding Pharmacy of America,…
The Compounding Pharmacy of America
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: The Compounding Pharmacy of America · 6216 Highland Place Way Ste 101-A · Knoxville, TN · 37919-4068
Is this the product you have?
- Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
- Lot codes and dates
- All lots distributed between November 2014 and May 2015; 05112015@22, 5/10/2016; 10202014@63, 10/20/2015; 10272014@17, 10/27/2015; 11102014@20, 11/10/2015; 12302014@8, 12/30/2015; 08252014@26, 8/25/2015; 08262014@20, 8/26/2015; 09052014@13, 9/5/2015; 01262015@15, 1/26/2016; 01022015@22, 1/2/2016; 02232015@50, 2/23/2016; 04132015@59, 4/12/2016; 04222015@40, 4/21/2016; 05062015@21, 5/5/2016; 06042014@17, 6/4/2015
This recall covers 382 products
The agency filed one notice per product. You are reading one of them; the other 381 are below.
369 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and 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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