RecallRadar

FDA Drug recall D-1471-2015

Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

On 2015-09-23 the FDA classified a Class II recall of Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN by The Compounding Pharmacy, citing lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1471-2015
ClassificationClass II
Statusterminated
Initiated2015-06-02
Published2015-09-23
Last updated2026-09-13 11:51 UTC
CompanyThe Compounding Pharmacy
DistributionUS

Product

Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

Reason

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

Identifiers

code_info
All lots distributed between November 2014 and May 2015; 12012014@59, 5/30/2015; 01122015@34, 7/11/2015; 02102015@42,…All lots distributed between November 2014 and May 2015; 12012014@59, 5/30/2015; 01122015@34, 7/11/2015; 02102015@42, 7/1/2015; 03162015@12, 9/12/2015; 04282015@59, 10/25/2015; 05052015@65, 11/1/2015

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1471-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.