Compounding Pharmacy Recalls LIPO-Tropic Injectable Due to Sterility Concerns
The Compounding Pharmacy of America is recalling LIPO-Tropic Injectable vials because FDA inspections found violations that may affect 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving potential sterility failures in injectable products are categorized as Severe (Score 4) due to the significant risk of infection or injury.
Plain-English summary
The Compounding Pharmacy of America is recalling LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature. The product was distributed nationwide between November 2014 and May 2015. The recall involves 305 ml vials.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations raise concerns about the assurance of sterility and potentially impact the overall quality of the product.
Consumers 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
- LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable
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
- 02262015@3
- 5/27/2015
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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