D-1446-2015 Class II Terminated

Recall Details

Biotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, the Compounding Pharmacy of America, Knoxville, TN

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

Nationwide

All lots distributed between November 2014 and May 2015; 05042015@46, 8/2/2015

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-1468-2015 Class II — Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, (June 2, 2015)
D-1470-2015 Class II — Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knox (June 2, 2015)