PlainRecalls
FDA Drug Moderate Class II Terminated

Lipo-B MMC I (SULFUR FREE) Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Reported: September 23, 2015 Initiated: June 2, 2015 #D-1683-2015

Product Description

Lipo-B MMC I (SULFUR FREE) Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Reason for Recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Details

Units Affected
1200 ml
Distribution
Nationwide
Location
Knoxville, TN

Frequently Asked Questions

What product was recalled?
Lipo-B MMC I (SULFUR FREE) Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN. Recalled by The Compounding Pharmacy of America. Units affected: 1200 ml.
Why was this product recalled?
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on September 23, 2015. Severity: Moderate. Recall number: D-1683-2015.