The Compounding Pharmacy of America

FDA Regulatory Profile

Summary

Total Recalls
383 (1 Class I)
510(k) Clearances
0
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0600-2018Class IHCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, CompJanuary 12, 2018
D-1718-2015Class IIQuad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, KJune 2, 2015
D-1546-2015Class IIHydromorphone 15 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, KnoJune 2, 2015
D-1482-2015Class IIFentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml IntrathecJune 2, 2015
D-1666-2015Class IIBi-Mix Medium (30/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, KnoxvillJune 2, 2015
D-1665-2015Class IIBi-Mix (20/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TNJune 2, 2015
D-1473-2015Class IIEstradiol 4 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TNJune 2, 2015
D-1599-2015Class IIMorphine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, KnoxvillJune 2, 2015
D-1626-2015Class IIProgesterone 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding PharmaJune 2, 2015
D-1478-2015Class IIEstradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Temperature, The CompoundinJune 2, 2015
D-1570-2015Class IIMethylcobalamin 10,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding PhaJune 2, 2015
D-1627-2015Class IIPyridoxine Hydrochloride 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, Protect from LJune 2, 2015
D-1557-2015Class IIHydroxocobalamin 10,000 mcg/ml Injection, Multi-Dose Vial, sterile, Refrigerate, The Compounding PhaJune 2, 2015
D-1762-2015Class IITri-Mix (15 mg/0.5 mg/5 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, June 2, 2015
D-1695-2015Class IILipovicine-Choline 100 mg/ml-Acorbic Acid 45 mg/ml Injectable, Multi-Dose Vial, Sterile, Room TemperJune 2, 2015
D-1713-2015Class IIMorphine 60 mg/ml + Fentanyl 12,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,400 mcg/ml Solution,June 2, 2015
D-1472-2015Class IIEstradiol 3 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TNJune 2, 2015
D-1550-2015Class IIHydromorphone 40 mg/ml + Bupivacaine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding PJune 2, 2015
D-1541-2015Class IIHydromorphone 1 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of AJune 2, 2015
D-1584-2015Class IIMitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The Compounding Pharmacy June 2, 2015