Lipovicine Modified II Injectable Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Lipovicine Modified II 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 source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe), particularly given the risk of sterility failure in an injectable product.
Plain-English summary
The Compounding Pharmacy of America is recalling Lipovicine Modified II Injectable, Multi-Dose Vial, Sterile, Room Temperature. The product was distributed nationwide in 331 ml quantities. The recall covers all lots distributed between November 2014 and May 2015, specifically including lot 04152015@29 with an expiration date of 7/14/2015, and lot 04212015@31 with an expiration date of 7/20/2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact The Compounding Pharmacy of America for instructions on return or disposal. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Lipovicine Modified II 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 (5)
- All lots distributed between November 2014 and May 2015
- 04152015@29
- 7/14/2015
- 04212015@31
- 7/20/2015
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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