PlainRecalls
FDA Drug Moderate Class II Terminated

Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

Reported: September 23, 2015 Initiated: June 2, 2015 #D-1475-2015

Product Description

Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

Reason for Recall

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

Details

Units Affected
144 pellets
Distribution
Nationwide
Location
Knoxville, TN

Frequently Asked Questions

What product was recalled?
Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN. Recalled by The Compounding Pharmacy of America. Units affected: 144 pellets.
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-1475-2015.