Compounded Injectable Recalled for Potential Sterility Issues
The Compounding Pharmacy of America is recalling SUPER LIPO Injectable due to FDA inspection findings of GMP violations that may 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 agency classification is FDA Class II. The rubric assigns a score of 4 (Severe) to FDA Class II recalls, particularly those involving potential sterility issues in injectable products which carry significant risk.
Plain-English summary
The Compounding Pharmacy of America is recalling SUPER LIPO Injectable, Multi-Dose Vial, Sterile, Room Temperature. The product was distributed nationwide in 394 ml vials. The recall covers all lots distributed between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, meaning there is a lack of assurance that the injectable is sterile.
Consumers and healthcare providers should stop using the affected product. The source text does not specify a particular action for disposal or return, but users should consult their healthcare provider regarding the recall.
The recalled product
- Product
- SUPER LIPO Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — 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 (9)
- All lots distributed between November 2014 and May 2015
- 03312015@51
- 6/11/2015
- 04142015@18
- 7/13/2015
- 03302015
- 6/28/2015
- 04302015@48
- 7/29/2015
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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