Reported Sep 23, 2015 · Terminated
Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
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?
- Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
- Lot codes and dates
- All lots distributed between November 2014 and May 2015; 12012014@59, 5/30/2015; 01122015@34, 7/11/2015; 02102015@42, 7/1/2015; 03162015@12, 9/12/2015; 04282015@59, 10/25/2015; 05052015@65, 11/1/2015
- Amount recalled
- 144 pellets
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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