Compounded Injectable Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling LIPO-EXTREME Injectable due to FDA inspection findings of GMP violations that impact sterility.
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 recall is classified as FDA Class II and involves a sterile injectable product where GMP violations impact sterility assurance, posing a risk of serious injury or death from infection, which aligns with the 'Severe' criteria for significant injury risk or Class II with potential for hospitalization.
Plain-English summary
The Compounding Pharmacy of America is recalling LIPO-EXTREME Injectable, Multi-Dose Vial, Sterile, Room Temperature. The product is a 105 ml injectable manufactured in Knoxville, Tennessee, and was distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, specifically including lot 03122015@79 with a date of 6/10/2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations create a lack of assurance regarding the sterility of the product, potentially impacting its overall quality. The agency has classified this recall as Class II.
Consumers and healthcare providers who have this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- LIPO-EXTREME Injectable, Multi-Dose Vial, Sterile, Room Temperature, 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
- 03122015@79
- 6/10/2015
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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