FDA Recalls MEGA-BURN Injectable Due to Sterility Concerns
The Compounding Pharmacy of America is recalling MEGA-BURN Injectable ROCK CREEK because FDA inspections found 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 and involves a sterile injectable product with a lack of assurance of sterility, which poses a significant risk of serious injury.
Plain-English summary
The Compounding Pharmacy of America is recalling MEGA-BURN Injectable ROCK CREEK, a multi-dose sterile vial. The recall involves 461 ml of the product distributed nationwide between November 2014 and May 2015.
The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. There is a lack of assurance that the product is sterile.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- MEGA-BURN Injectable ROCK CREEK, 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 (13)
- All lots distributed between November 2014 and May 2015
- 02272015@77
- 5/28/2015
- 03122015@85
- 6/10/2015
- 03252015@29
- 6/23/2015
- 04072015@54
- 7/6/2015
- 04172015@69
- 7/16/2015
- 04272015@45
- 7/26/2015
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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