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-1721-2015Class IITri-Mix Injectable, The Compounding Pharmacy of America, Knoxville, TNJune 2, 2015
D-1753-2015Class IITestosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, The Compounding Pharmacy June 2, 2015
D-1792-2015Class IITri-Mix ST1 (30 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TNJune 2, 2015
D-1768-2015Class IITri-Mix (18/0.6/5.88) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, KJune 2, 2015
D-1778-2015Class IITri-Mix (30/1/20) Injectable, The Compounding Pharmacy of America, Knoxville, TNJune 2, 2015
D-1488-2015Class IIFentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free,The CompouJune 2, 2015
D-1784-2015Class IITri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TNJune 2, 2015
D-1468-2015Class IIEstradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TNJune 2, 2015
D-1719-2015Class IITRI-MIX (1/1/40) (MFG) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy oJune 2, 2015
D-1730-2015Class IIHydromorphone 80 mg/ml + Clonidine 1,800 mcg/ml + Baclofen 730 mcg/ml Intrathecal Solution, The CompJune 2, 2015
D-1446-2015Class IIBiotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, the Compounding Pharmacy of AmeJune 2, 2015
D-1437-2015Class IIAlprostadil 100 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, KnoxvilJune 2, 2015
D-1470-2015Class IIEstradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TNJune 2, 2015
D-1664-2015Class IIBi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America,June 2, 2015
D-1635-2015Class IISodium Tetradecyl Sulfate 5% Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding PharJune 2, 2015
D-1445-2015Class IIBaclofen 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of AJune 2, 2015
D-1479-2015Class IIEstradiol Valerate 40 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding June 2, 2015
D-1529-2015Class IIHCG 3,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of AmericaJune 2, 2015
D-1461-2015Class IIDexpanthenol 215 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy June 2, 2015