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-1628-2015Class IISelenium 200 mcg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding PharmacyJune 2, 2015
D-1676-2015Class IIHydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrathecal Solution, Sterile-June 2, 2015
D-1576-2015Class IIMethylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injection, MuJune 2, 2015
D-1755-2015Class IITestosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The CompoundJune 2, 2015
D-1461-2015Class IIDexpanthenol 215 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy June 2, 2015
D-1688-2015Class IILIPO-VITE Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of AmericaJune 2, 2015
D-1443-2015Class IIAscorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile, Refrigerate, The CoJune 2, 2015
D-1731-2015Class IIHydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, The ComJune 2, 2015
D-1543-2015Class IIHydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The June 2, 2015
D-1694-2015Class IILipovicine Modified II Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding PharmJune 2, 2015
D-1584-2015Class IIMitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The Compounding Pharmacy June 2, 2015
D-1718-2015Class IIQuad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, KJune 2, 2015
D-1473-2015Class IIEstradiol 4 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TNJune 2, 2015
D-1563-2015Class IILidocaine 2% with Epinephrine 1:100,000 (Buffered) Vial, Sterile, Refrigerate, The Compounding PharmJune 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-1664-2015Class IIBi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America,June 2, 2015