Compounded Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable due to lack of assurance of sterility identified during an FDA inspection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential sterility issues in injectable products which carry significant risk.
Plain-English summary
The Compounding Pharmacy of America, located in Knoxville, Tennessee, is recalling Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable. The product is an 8 ml injectable solution. The recall covers all lots distributed nationwide between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. Specifically, there is a lack of assurance of sterility for the affected products.
Consumers and healthcare providers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Compounded Injectable
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All lots distributed between November 2014 and May 2015
- 01272015@28
- 7/26/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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