The Compounding Pharmacy of America
The Compounding Pharmacy of America appears in FDA public data with 383 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (D-0600-2018, Class I) was initiated on January 12, 2018.
Summary
- Total Recalls
- 383 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 1
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0600-2018 | Class I | HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Comp | January 12, 2018 |
| D-1737-2015 | Class II | Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmac | June 2, 2015 |
| D-1610-2015 | Class II | Morphine 50 mg/ml + Clonidine 200 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharma | June 2, 2015 |
| D-1731-2015 | Class II | Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, The Com | June 2, 2015 |
| D-1694-2015 | Class II | Lipovicine Modified II Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharm | June 2, 2015 |
| D-1725-2015 | Class II | Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of A | June 2, 2015 |
| D-1718-2015 | Class II | Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, K | June 2, 2015 |
| D-1749-2015 | Class II | Testosterone 60 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN | June 2, 2015 |
| D-1518-2015 | Class II | HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America | June 2, 2015 |
| D-1627-2015 | Class II | Pyridoxine Hydrochloride 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, Protect from L | June 2, 2015 |
| D-1442-2015 | Class II | Ascorbic Acid 500 mg/ml Injectable Vial, Sterile Multi-Dose Vial, Refrigerate, The Compounding Pharm | June 2, 2015 |
| D-1546-2015 | Class II | Hydromorphone 15 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Kno | June 2, 2015 |
| D-1687-2015 | Class II | LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of Amer | June 2, 2015 |
| D-1690-2015 | Class II | Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection, Multi-Dose Vial, Sterile, Room Temperature, Th | June 2, 2015 |
| D-1443-2015 | Class II | Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile, Refrigerate, The Co | June 2, 2015 |
| D-1763-2015 | Class II | Tri-Mix (17 mg/0.5 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, | June 2, 2015 |
| D-1761-2015 | Class II | Tri-Mix (10/0.174/16) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxvil | June 2, 2015 |
| D-1681-2015 | Class II | Hydromorphone 70 mg/ml +Fentanyl 16,000 mcg/ml + Bupivacaine 12 mg/ml + Clonidine 1,000 mcg/ml, Bacl | June 2, 2015 |
| D-1797-2015 | Class II | Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable, The Compounding Pharmacy of America, Knoxville, T | June 2, 2015 |
| D-1758-2015 | Class II | Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compound | June 2, 2015 |