HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN

FDA recall notice · announced September 23, 2015 · The Compounding Pharmacy

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Notes

Distribution: Nationwide
Lot/code information: All lots distributed between November 2014 and May 2015; 05062015@32, 8/4/2015; 02272015@16, 5/28/2015; 03032015@33, 6/1/2015; 03042015@36, 6/2/2015; 03062015@43, 6/4/2015; 03092015@77, 6/7/2015; 03092015@92, 6/7/2015; 03132015@17, 11/2015; 03162015@23, 14/2015; 03172015@40, 5/2015; 03232015@39, 6/21/2015; 03242015@23, 6/22/2015; 03242015@29, 6/22/2015; 04162015@46, 7/15/2015; 04012015@8, 6/30/2015; 04062015@10, 7/5/2015; 04072015@17, 7/6/2015; 04142015@2, 7/13/2015; 04132015@34, 7/12/2015; 04202015@45, 7/19/2015; 04172015@63, 7/16/2015; 04272015@5, 7/26/2015; 05082015@44, 8/6/2015
Quantity: 1558 ml total
Status: Terminated
Products in this recall event:
- Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN (D-1744-2015)
- HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN (D-1523-2015)
- Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1549-2015)
- Morphine 60 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1612-2015)
- Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN (D-1534-2015)
- Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1675-2015)
- Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1682-2015)
- Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1492-2015)
- Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1702-2015)
- Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN (D-1743-2015)
- Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofen 750 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN (D-1732-2015)
- Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN (D-1789-2015)
- B-Complex 100 mg/ml Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1726-2015)
- PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN (D-1740-2015)
- Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1701-2015)
- Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN (D-1586-2015)
- Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN (D-1718-2015)
- Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1623-2015)
- L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1561-2015)
- Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1547-2015)
- Morphine 50 mg/ml + Clonidine 200 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1610-2015)
- Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The Compounding Pharmacy of America, Knoxville, TN (D-1584-2015)
- Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1435-2015)
- HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN (D-1512-2015)
- Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN (D-1764-2015)
- Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1725-2015)
- Tri-Mix (6.9/0.575/39.375) Injectable, The Compounding Pharmacy of America, Knoxville, TN (D-1787-2015)
- Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN (D-1720-2015)
- Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN (D-1471-2015)
- Lipovicine Modified II Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN (D-1694-2015)
- Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN (D-1790-2015)
- Estradiol 8 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN (D-1476-2015)
- Tri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN (D-1784-2015)
- Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1491-2015)
- Tri-Mix T-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America, Knoxville, TN (D-1808-2015)
- Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN (D-1568-2015)
- Morphine 50 mg/ml + Fentanyl 1,500 mcg/ml + Baclofen 800 mcg/ml +Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1706-2015)
- Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen 450 mcg/ml, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1709-2015)
- Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 Injectable, The Compounding Pharmacy of America, Knoxville, TN (D-1795-2015)
- Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, The Compounding Pharmacy of America, Knoxville, TN (D-1809-2015)
- Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1637-2015)
- Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN (D-1690-2015)
- Tri-Mix (30/0.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN (D-1774-2015)
- MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN (D-1577-2015)
- Magnesium Sulfate 500 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1565-2015)
- Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1556-2015)
- LIPO-VITE III, Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN (D-1689-2015)
- Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1543-2015)
- TRI-MIX (1/1/40) (MFG) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN (D-1719-2015)
- Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN (D-1457-2015)
- Tri-Mix (37.5/2/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN (D-1785-2015)
- B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1444-2015)
- Lidocaine 1% Injection, The Compounding Pharmacy of America, Knoxville, TN (D-1562-2015)
- Tri-Mix (30/1/22) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN (D-1781-2015)
- Testosterone 37.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN (D-1748-2015)
- Fentanyl 5,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1495-2015)
- Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN (D-1488-2015)
- 5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN (D-1432-2015)
- HCG 2,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN (D-1521-2015)
- Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment, grams, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1618-2015)
- Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1569-2015)
- Hyaluronidase 150 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1538-2015)
- Zinc 5 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1662-2015)
- HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN (D-1522-2015)
- Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN (D-1453-2015)
- Tri-Mix (15 mg/0.5 mg/20 mcg) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN (D-1722-2015)
- MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN (D-1739-2015)
- Testosterone 80 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN (D-1656-2015)
- Acetyl-L-Carnitine 500 mg/ml, Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN (D-1434-2015)
- Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN (D-1731-2015)
- Tri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN (D-1806-2015)
- Tri-Mix (18 mg/0.6 mg/5.88 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN (D-1767-2015)
- HCG 5,000 IU/ml + Methylcobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1516-2015)
- Hyaluronidase 150 units/ml Injection, ml, Sterile, Preservative Free, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1537-2015)
- HCG 10,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN (D-1520-2015)
- Tri-Mix (25/2.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN (D-1773-2015)
- Testosterone 75 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN (D-1655-2015)
- Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN (D-1753-2015)
- Morphine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1736-2015)
- Fentanyl 7,500 mcg/ml, + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1500-2015)
- Tri-Mix (25/2.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN (D-1772-2015)
- Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN (D-1631-2015)
- Folic Acid 5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1502-2015)
- Sermorelin 300 mcg/ml + GHRP-2 300 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN (D-1633-2015)
- LIPO-EXTREME Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN (D-1686-2015)
- Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN (D-1616-2015)
- Oxytocin 100 units/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1619-2015)
- Sermorelin/GHRP2 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN (D-1630-2015)
- Morphine 30 mg/ml + Clonidine 250 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1595-2015)
- Fentanyl 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN (D-1489-2015)
- Buckshot Injectable, Multi-Dose, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN (D-1667-2015)
- Morphine 30 mg/ml + Bupivacaine 5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1594-2015)
- Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 15 mg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1710-2015)
- LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN (D-1687-2015)
- Tri-Mix (17.7/0.59/6) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN (D-1766-2015)
- Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1559-2015)
- Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable, The Compounding Pharmacy of America, Knoxville, TN (D-1797-2015)
- Morphine 25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1592-2015)
- Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1738-2015)
- Hydromorphone 60 mg/ml + Bupivacaine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1553-2015)
- Biotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, the Compounding Pharmacy of America, Knoxville, TN (D-1446-2015)
- Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN (D-1583-2015)
- Testosterone 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN (D-1746-2015)
- Fentanyl 2,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN (D-1493-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.