Lipo-DEN III Injection Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Lipo-DEN III Injection 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for potential serious, reversible health consequences.
Plain-English summary
The Compounding Pharmacy of America is recalling Lipo-DEN III Injection, a sterile multi-dose vial product. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product was distributed nationwide between November 2014 and May 2015. The recall covers 2,733 ml of the product across multiple lots with expiration dates ranging from May 2015 to July 2015.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Lipo-DEN III Injection, 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 (15)
- All lots distributed between November 2014 and May 2015
- 03022015@26
- 5/31/2015
- 02272015@22
- 5/28/2015
- 03092015@75
- 6/7/2015
- 04092015@97
- 7/8/2015
- 04092015@37
- 03022015@78
- 04102015@6
- 7/9/2015
- 04242015@31
- 7/23/2015
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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