MEGA-BURN IV Injectable (Compounding Pharmacy) – sterility risk (2015)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MEGA-BURN IV Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Brand
The Compounding Pharmacy of America
Lot Codes / Batch Numbers
All lots distributed between November 2014 and May 2015, 04142015@6, 7/13/2015, 03132015@9, 6/11/2015, 03122015@100, 6/10/2015, 04142015@15, 7/13/2015, 03302015@46, 6/28/2015, 04302015@49, 7/29/2015
Products Sold
All lots distributed between November 2014 and May 2015; 04142015@6, 7/13/2015; 03132015@9, 6/11/2015; 03122015@100, 6/10/2015; 04142015@15, 7/13/2015; 03302015@46, 6/28/2015; 04302015@49, 7/29/2015
The Compounding Pharmacy of America is recalling MEGA-BURN IV Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of Ame due to Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026