Home / Recalls / The Compounding Pharmacy of America / D-1482-2015

D-1482-2015 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
22 ml total volume

Product Description

Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, 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; 03092015@16, 6/7/2015

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-1718-2015 Class II — Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Ph (June 2, 2015)
  • D-1599-2015 Class II — Morphine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy (June 2, 2015)
  • D-1666-2015 Class II — Bi-Mix Medium (30/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy (June 2, 2015)
  • D-1665-2015 Class II — Bi-Mix (20/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of Amer (June 2, 2015)
  • D-1473-2015 Class II — Estradiol 4 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxv (June 2, 2015)
  • D-1695-2015 Class II — Lipovicine-Choline 100 mg/ml-Acorbic Acid 45 mg/ml Injectable, Multi-Dose Vial, (June 2, 2015)
  • D-1626-2015 Class II — Progesterone 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, Th (June 2, 2015)
  • D-1478-2015 Class II — Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Tempera (June 2, 2015)
  • D-1584-2015 Class II — Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The C (June 2, 2015)