Home / Recalls / The Compounding Pharmacy of America / D-1468-2015

D-1468-2015 Class II Terminated

Recalled by The Compounding Pharmacy of America — Knoxville, TN

Recall Details

Product Type
Drugs
Report Date
September 23, 2015
Initiation Date
June 2, 2015
Termination Date
February 10, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
120 pellets

Product Description

Estradiol 18 mg, Sterile Pellet, 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

Distribution Pattern

Nationwide

Code Information

All lots distributed between November 2014 and May 2015; 12112014@4, 6/9/2015; 02102015@18, 8/9/2015; 03022015@59, 8/29/2015; 03242015@96, 9/20/2015; 04292015@16, 10/26/2015

Other recalls by The Compounding Pharmacy of America

  • D-0600-2018 Class I — HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, St (January 12, 2018)
  • D-1721-2015 Class II — Tri-Mix Injectable, The Compounding Pharmacy of America, Knoxville, TN (June 2, 2015)
  • D-1753-2015 Class II — Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, The C (June 2, 2015)
  • D-1792-2015 Class II — Tri-Mix ST1 (30 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of Americ (June 2, 2015)
  • D-1768-2015 Class II — Tri-Mix (18/0.6/5.88) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Ph (June 2, 2015)
  • D-1778-2015 Class II — Tri-Mix (30/1/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN (June 2, 2015)
  • D-1488-2015 Class II — Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preserva (June 2, 2015)
  • D-1784-2015 Class II — Tri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America (June 2, 2015)
  • D-1719-2015 Class II — TRI-MIX (1/1/40) (MFG) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Co (June 2, 2015)
  • D-1470-2015 Class II — Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knox (June 2, 2015)