D-1731-2015 Class II Terminated

Recall Details

Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, 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; 03022015@6, 5/31/2015; 04172015@25, 6/16/2015; 05082015@35, 7/7/2015

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-1628-2015 Class II — Selenium 200 mcg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The (June 2, 2015)
D-1688-2015 Class II — LIPO-VITE Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding (June 2, 2015)
D-1576-2015 Class II — Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 (June 2, 2015)
D-1755-2015 Class II — Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Tempe (June 2, 2015)
D-1461-2015 Class II — Dexpanthenol 215 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The C (June 2, 2015)
D-1563-2015 Class II — Lidocaine 2% with Epinephrine 1:100,000 (Buffered) Vial, Sterile, Refrigerate, T (June 2, 2015)
D-1443-2015 Class II — Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile, (June 2, 2015)
D-1543-2015 Class II — Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Pre (June 2, 2015)
D-1664-2015 Class II — Bi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compounding (June 2, 2015)