Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 08, 2025 and include a total of 16999 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1325-2016 | 04-20-2016 | HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0932-68 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 90 | Class II | Terminated |
| D-1275-2016 | 04-20-2016 | Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0186-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 725 | Class II | Terminated |
| D-1286-2016 | 04-20-2016 | Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0521-67 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 20 | Class II | Terminated |
| D-1345-2016 | 04-20-2016 | PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a box, Kwang Chow Pharm. Ind. Corp., remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / 84 bottles | Class II | Terminated |
| D-1256-2016 | 04-20-2016 | Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0011-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 2100 syringes | Class II | Terminated |
| D-1358-2016 | 04-20-2016 | FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individually labeled pieces Net Wt. 0.32oz (10g) within a box, MANUFACTURED BY: TIANJIN MAEDICAL & PHARMACEUTICAL CO., LTD. ADDREST: 96 BAWAEI ROAD, HEDONG COUNTY, TIANJIN CITY, remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / 97 boxes | Class II | Terminated |
| D-1299-2016 | 04-20-2016 | Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0769-04 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 384 | Class II | Terminated |
| D-1291-2016 | 04-20-2016 | Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0683-68 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 5 | Class II | Terminated |
| D-1326-2016 | 04-20-2016 | HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0933-75 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 120 | Class II | Terminated |
| D-1313-2016 | 04-20-2016 | Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0867-71 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 400 | Class II | Terminated |
| D-1306-2016 | 04-20-2016 | Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0819-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 50 | Class II | Terminated |
| D-1258-2016 | 04-20-2016 | Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0029-01 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 150 bags | Class II | Terminated |
| D-1292-2016 | 04-20-2016 | Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0684-68 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 20 | Class II | Terminated |
| D-1268-2016 | 04-20-2016 | Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PAB Container); Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0146-47 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 12 | Class II | Terminated |
| D-1357-2016 | 04-20-2016 | Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, Net Wt. 15ml, packaged in a bottle within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd, Imported by Murray Int'l Trading Co., Inc. New York, NY 10013, UPC 7 67533 86115 6, remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / 17 boxes | Class II | Terminated |
| D-1280-2016 | 04-20-2016 | Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0223-48 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 18 | Class II | Terminated |
| D-1355-2016 | 04-20-2016 | FARSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / Unknown | Class II | Terminated |
| D-1309-2016 | 04-20-2016 | Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0853-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 10 | Class II | Terminated |
| D-1272-2016 | 04-20-2016 | Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0174-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 24 | Class II | Terminated |
| D-1324-2016 | 04-20-2016 | Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0927-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 2735 | Class II | Terminated |
| D-1337-2016 | 04-20-2016 | Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0964-70 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 1500 | Class II | Terminated |
| D-1294-2016 | 04-20-2016 | Ketamine 100mg/mL 1mL fill 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0709-78 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 600 | Class II | Terminated |
| D-1352-2016 | 04-20-2016 | PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count bottles within a box, BEIJING TUNG JEN TANG. BEIJING CHINA; remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / Unknown | Class II | Terminated |
| D-1314-2016 | 04-20-2016 | Fentanyl Citrate 10 mcg/mL(PF) in 0.9% Sodium Chloride 100 mL fill bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0869-48 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 75 | Class II | Terminated |
| D-1277-2016 | 04-20-2016 | Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0189-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 10 | Class II | Terminated |
| D-1323-2016 | 04-20-2016 | Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0925-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 175 | Class II | Terminated |
| D-1289-2016 | 04-20-2016 | Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0610-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 1450 | Class II | Terminated |
| D-1333-2016 | 04-20-2016 | Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0955-70 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 1925 | Class II | Terminated |
| D-1293-2016 | 04-20-2016 | HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0702-68 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 100 | Class II | Terminated |
| D-1308-2016 | 04-20-2016 | Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0826-77 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 260 | Class II | Terminated |
| D-1259-2016 | 04-20-2016 | Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0100-69 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 4050 syringes | Class II | Terminated |
| D-1269-2016 | 04-20-2016 | Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0148-48 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 95 | Class II | Terminated |
| D-1263-2016 | 04-20-2016 | Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0118-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 200 | Class II | Terminated |
| D-1267-2016 | 04-20-2016 | Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0138-67 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 40 | Class II | Terminated |
| D-1301-2016 | 04-20-2016 | Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 1200 | Class II | Terminated |
| D-1332-2016 | 04-20-2016 | Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0946-70 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 50 | Class II | Terminated |
| D-1288-2016 | 04-20-2016 | Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0608-75 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 40 | Class II | Terminated |
| D-1297-2016 | 04-20-2016 | Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 72 | Class II | Terminated |
| D-1349-2016 | 04-20-2016 | CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / 48 bottles | Class II | Terminated |
| D-1346-2016 | 04-20-2016 | ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, UPC 0 49987 01144 9, remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / 204 bottles | Class II | Terminated |
| D-1335-2016 | 04-20-2016 | Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0960-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 1675 | Class II | Terminated |
| D-1307-2016 | 04-20-2016 | Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0823-75 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 30 | Class II | Terminated |
| D-1321-2016 | 04-20-2016 | Bupivacaine HCI 0.125% in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0909-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 55 | Class II | Terminated |
| D-1316-2016 | 04-20-2016 | Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0876-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 300 | Class II | Terminated |
| D-1318-2016 | 04-20-2016 | Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0885-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 216 | Class II | Terminated |
| D-1343-2016 | 04-20-2016 | Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 70 | Class II | Terminated |
| D-1350-2016 | 04-20-2016 | Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / 96 bottles | Class II | Terminated |
| D-1265-2016 | 04-20-2016 | Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0120-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 280 | Class II | Terminated |
| D-1311-2016 | 04-20-2016 | Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0855-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 250 | Class II | Terminated |
| D-1282-2016 | 04-20-2016 | Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0407-03 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 72 | Class II | Terminated |
| D-1344-2016 | 04-20-2016 | Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN, NDC 45183-0996-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 595 | Class II | Terminated |
| D-1295-2016 | 04-20-2016 | Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0735-03 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 384 | Class II | Terminated |
| D-1351-2016 | 04-20-2016 | LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3 tubes per packet within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd.; Imported by: Murray Int'l Trading Co., Inc., New York, NY 10013; UPC 7 67533 86925 1, remaining labeling contains Chinese characters. | Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. | Murray International Trading Co., Inc. / 178 boxes | Class II | Terminated |
| D-1285-2016 | 04-20-2016 | Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0505-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 5 | Class II | Terminated |
| D-1262-2016 | 04-20-2016 | Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey), Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0114-48 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 12 | Class II | Terminated |
| D-1315-2016 | 04-20-2016 | Morphine Sulfate 1 mg/mL in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0875-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 215 | Class II | Terminated |
| D-1284-2016 | 04-20-2016 | Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0504-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 10 | Class II | Terminated |
| D-1331-2016 | 04-20-2016 | Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0942-03 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 129 | Class II | Terminated |
| D-1273-2016 | 04-20-2016 | Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0177-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 40 | Class II | Terminated |
| D-1303-2016 | 04-20-2016 | Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0806-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 70 | Class II | Terminated |
| D-1271-2016 | 04-20-2016 | Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0173-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 40 | Class II | Terminated |
| D-1305-2016 | 04-20-2016 | HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0815-67 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 560 | Class II | Terminated |
| D-1260-2016 | 04-20-2016 | Succinylcholine Chloride 20 mg/mL injection , 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0104-70 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 650 syringes | Class II | Terminated |
| D-1274-2016 | 04-20-2016 | Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0180-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 225 | Class II | Terminated |
| D-0924-2016 | 04-18-2016 | Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 5 bags | Class II | Terminated |
| D-0946-2016 | 04-18-2016 | Vancomycin 1750 mg in 270 mL 0.9% NS bag,FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 54 bags | Class II | Terminated |
| D-0911-2016 | 04-18-2016 | 0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / a) 6 bags b) 1 bag c) 2 bags | Class II | Terminated |
| D-0912-2016 | 04-18-2016 | 1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq., FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 7 bags | Class II | Terminated |
| D-0913-2016 | 04-18-2016 | 70% Ethanol-lock Solution, 2 mL Syringe, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 18 syringes | Class II | Terminated |
| D-0940-2016 | 04-18-2016 | Water for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 7 bags | Class II | Terminated |
| D-0923-2016 | 04-18-2016 | Deferoxamine 4 grams/NS 101 mL Cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 3 cassettes | Class II | Terminated |
| D-0939-2016 | 04-18-2016 | TPN 2, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 86 bags | Class II | Terminated |
| D-0935-2016 | 04-18-2016 | Piperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 53 bags | Class II | Terminated |
| D-0930-2016 | 04-18-2016 | Milrinone 200 mcg/mL in a) D5W-300 mL, b) D5W-400 mL, c) D5W-500 mL and d) D5W-600 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / a) 15 bags, b) 15 bags, c) 15 bags, d) 4 bags | Class II | Terminated |
| D-0922-2016 | 04-18-2016 | Deferoxamine 2 grams/51 mL NS cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 5 cassettes | Class II | Terminated |
| D-0937-2016 | 04-18-2016 | Sodium Chloride 0.9% 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 7 bags | Class II | Terminated |
| D-0943-2016 | 04-18-2016 | Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 59 bags | Class II | Terminated |
| D-0926-2016 | 04-18-2016 | Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / a) 16 bags and b) 18 bags | Class II | Terminated |
| D-0916-2016 | 04-18-2016 | Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / a) 39 bags and b) 8 bags | Class II | Terminated |
| D-0938-2016 | 04-18-2016 | TPN 1, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 7 bags | Class II | Terminated |
| D-0947-2016 | 04-18-2016 | Vancomycin 1 grams in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 2 bags | Class II | Terminated |
| D-0948-2016 | 04-18-2016 | Vancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 11 bags | Class II | Terminated |
| D-0945-2016 | 04-18-2016 | Vancomycin 1500 mg in 270 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 88 bags | Class II | Terminated |
| D-0925-2016 | 04-18-2016 | Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1750 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / a) 10 bags, b) 23 bags, c) 9 bags, d) 6 bags | Class II | Terminated |
| D-0941-2016 | 04-18-2016 | Vancomycin 500 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 1 bag | Class II | Terminated |
| D-0917-2016 | 04-18-2016 | Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 16 bags | Class II | Terminated |
| D-0929-2016 | 04-18-2016 | Meropenem 2 grams in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 22 bags | Class II | Terminated |
| D-0927-2016 | 04-18-2016 | Hydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 3 bags | Class II | Terminated |
| D-0942-2016 | 04-18-2016 | Vancomycin 750 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 47 bags | Class II | Terminated |
| D-0919-2016 | 04-18-2016 | Clindamycin 900 mg in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 16 bags | Class II | Terminated |
| D-0915-2016 | 04-18-2016 | Cefazolin 6 grams in 292 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, Arkansas | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 11 bags | Class II | Terminated |
| D-0921-2016 | 04-18-2016 | Daptomycin 650 mg in 50 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 14 bags | Class II | Terminated |
| D-0914-2016 | 04-18-2016 | Ascorbic Acid 500 mg (1 mL) Syringe, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 21 syringes | Class II | Terminated |
| D-0928-2016 | 04-18-2016 | Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 24 bags | Class II | Terminated |
| D-0933-2016 | 04-18-2016 | Piperacillin-Tazobactam 9 grams/NS 302 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 4 bags | Class II | Terminated |
| D-0920-2016 | 04-18-2016 | D5 1/2 NS 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 6 bags | Class II | Terminated |
| D-0918-2016 | 04-18-2016 | Ceftriaxone 2 gram in 100 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 32 bags | Class II | Terminated |
| D-0944-2016 | 04-18-2016 | Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance. | Baptist Health Medical Towers Pharmacy and Infusion Services / 84 bags | Class II | Terminated |
| D-0931-2016 | 04-18-2016 | Nafcillin 3 grams in 277 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 7 bags | Class II | Terminated |
| D-0932-2016 | 04-18-2016 | Nafcillin 12 grams in 322 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR | Lack of Sterility Assurance | Baptist Health Medical Towers Pharmacy and Infusion Services / 11 bags | Class II | Terminated |
