Reported Sep 23, 2015 · Terminated
MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, 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?
- MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Lot codes and dates
- All lots distributed between November 2014 and May 2015; 04212015@10, 7/20/2015; 02232015@86, 5/24/2015; 02252015@79, 5/26/2015; 03112015@21, 6/9/2015; 03232015@40, 6/21/2015; 03242015@76, 6/22/2015; 03312015@60, 6/29/2015; 03272015@27, 6/25/2015; 04022015@62, 7/1/2015; 04072015@55, 7/6/2015; 04142015@59, 7/13/2015; 04212015@30, 7/20/2015; 04212015@54, 7/20/2015; 04222015@31, 7/21/2015; 05042015@64, 8/2/2015; 05052015@60, 8/3/2015; 04272015@77, 7/26/2015; 04292015@14, 7/28/2015; 04292015@23, 7/28/2015; 05052015@92, 8/3/2015; 05082015@23, 8/6/2015; 05012015@11, 7/30/2015; 05052015@98, 8/3/2015
- Amount recalled
- 3513 ml
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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