Reported Sep 23, 2015 · Terminated

Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, 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

Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Lot codes and dates: All lots distributed between November 2014 and May 2015; 01082015@10, 7/7/2015; 12022014@44, 5/31/2015; 12192014@14, 6/17/2015; 01072015@22, 7/6/2015; 01262015@83, 7/25/2015; 02092015@12, 8/8/2015 02132015@5, 8/12/2015; 02202015@19, 8/19/2015; 02192015@24, 8/18/2015; 03022015@49, 8/29/2015; 03302015@1, 9/26/2015; 03312015@12, 9/27/2015; 04012015@63, 9/28/2015; 04162015@37, 10/13/2015; 05042015@37, 10/31/2015
Amount recalled: 307 ml total

The agency filed one notice per product. You are reading one of them; the other 381 are below.

369 more are in the archive.

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.

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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