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 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1057-2016 | 05-05-2016 | Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03 | Discoloration: presence of scuffing marks on tablets. | KVK-Tech, Inc. / 9360 bottles of lot # 12825A and 7284 bottles of lot # 12937A | Class III | Terminated |
| D-1385-2016 | 05-05-2016 | 10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8480, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-480-50 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 30 bags | Class II | Terminated |
| D-1421-2016 | 05-05-2016 | 5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-809-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 2,256 Medical Cassettes | Class II | Terminated |
| D-1408-2016 | 05-05-2016 | 20 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8146, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-189-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 10 bags | Class II | Terminated |
| D-1388-2016 | 05-05-2016 | 16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1.5 mL in 3 mL BD Syringe, Service Code 2T6228, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-228-96 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 230 BD syringes | Class II | Terminated |
| D-1362-2016 | 05-05-2016 | 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250 mL White Smiths Medical Cassette (NDC 615530-933-11) f) 250 mL Yellow Smiths Medical Cassette (NDC 61553-190-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ; | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 2,194 bags and cassettes | Class II | Terminated |
| D-1404-2016 | 05-05-2016 | 2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8892, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-882-48 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 85 Medical Cassettes | Class II | Terminated |
| D-1410-2016 | 05-05-2016 | 20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8494, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-494-61 | Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. | Pharmedium Services, LLC / 25 bags | Class II | Terminated |
| D-0867-2016 | 05-04-2016 | OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04 | Failed Impuities/Degradation Specifications | Fresenius Kabi USA, LLC / 40,280 vials | Class II | Terminated |
| D-0866-2016 | 05-04-2016 | OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01. | Failed Impuities/Degradation Specifications | Fresenius Kabi USA, LLC / 355,150 vials | Class II | Terminated |
| D-1045-2016 | 05-02-2016 | Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01 | Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing. | Sandoz, Inc / 78,606 bottles | Class III | Terminated |
| D-1046-2016 | 05-02-2016 | Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01 | Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing. | Sandoz, Inc / N/A | Class III | Terminated |
| D-0220-2017 | 04-29-2016 | BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C. | Marketed without an approved NDA/ANDA - presence of undeclared sildenafil. | Making It a Lifestyle / 1000 bottles | Class I | Terminated |
| D-0222-2017 | 04-29-2016 | 3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C. | Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. | Making It a Lifestyle / 1000 bottles | Class II | Terminated |
| D-0221-2017 | 04-29-2016 | BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C. | Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. | Making It a Lifestyle / 1000 bottles | Class I | Terminated |
| D-0858-2016 | 04-28-2016 | Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30 | Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered. | Lymol Medical / 25,007 canisters | Class II | Terminated |
| D-0857-2016 | 04-28-2016 | Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30. | Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found. | Pfizer Inc. / 68, 214 bottles | Class II | Terminated |
| D-0956-2016 | 04-27-2016 | Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21 Package NDCs: 0169-7704-21; 0169-7704-92; 0169-7705-21; 0169-7705-92; 0169-7708-21; 0169-7708-92; 0169-7703-11; 0169-7703-91; 0169-7703-21; 0169-7703-92 | Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step | Novo Nordisk Inc / 723 pens | Class II | Terminated |
| D-1029-2016 | 04-27-2016 | Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1 | Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial. | Genzyme Corporation / Genzyme Biosurgery / 2350 vials | Class III | Terminated |
| D-0868-2016 | 04-27-2016 | Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 | Lack of Assurance of Sterility: Due to potential for leaking bags. | Teva North America / 546 bags | Class II | Terminated |
| D-1037-2016 | 04-25-2016 | Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37 Package NDCs: 63323-472-03; 63323-472-17; 63323-472-01; 63323-472-37; 63323-463-01; 63323-463-57; 63323-461-01; 63323-461-57; 63323-468-02; 63323-468-37; 63323-468-01; 63323-468-17 | Presence of Particulate Matter: Glass particulate found in sterile injectable product | Fresenius Kabi USA, LLC / 69225 units | Class II | Terminated |
| D-1058-2016 | 04-22-2016 | CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523 | Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP. | Dr. Reddy's Laboratories, Inc. / 84,240 bottles | Class III | Terminated |
| D-0839-2016 | 04-22-2016 | Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0 | Labeling: Not elsewhere classified - count on the label was incorrect. | A-S Medication Solutions LLC. / 2730 bottles | Class III | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-1300-2016 | 04-20-2016 | Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0796-48 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 45 | Class II | Terminated |
| D-1278-2016 | 04-20-2016 | HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0190-78 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 4500 | Class II | Terminated |
| D-1356-2016 | 04-20-2016 | PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8gm containers within a box, PING ON OINTMENT CO LTD, PING ON OINTMENT INTERNATIONAL LTD, 149 Queen's Road West, Hong Kong, UPC 8 33679 00001 5, 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. / 216 packets | Class II | Terminated |
| D-1354-2016 | 04-20-2016 | WUPOOSER 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-1317-2016 | 04-20-2016 | Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0877-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 45 | Class II | Terminated |
| D-1270-2016 | 04-20-2016 | Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0171-01 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 105 | Class II | Terminated |
| D-1322-2016 | 04-20-2016 | Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0920-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 2175 | Class II | Terminated |
| D-1334-2016 | 04-20-2016 | Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0957-69 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 2300 | Class II | Terminated |
| D-1290-2016 | 04-20-2016 | Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 142 | 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-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-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-1327-2016 | 04-20-2016 | Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0934-70 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 800 | Class II | Terminated |
| D-1340-2016 | 04-20-2016 | Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0972-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 275 | Class II | Terminated |
| D-1353-2016 | 04-20-2016 | GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU 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-1264-2016 | 04-20-2016 | Propofol1% 10mg/mL injection, 20 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0119-73 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 2580 | Class II | Terminated |
| D-1261-2016 | 04-20-2016 | Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0106-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 1575 | Class II | Terminated |
| D-1347-2016 | 04-20-2016 | FUCONPO CAPSULE, packaged in a 30-count bottle 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. / unknown | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-1257-2016 | 04-20-2016 | Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0019-02 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 130 bags | Class II | Terminated |
| D-1330-2016 | 04-20-2016 | Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0939-70 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 800 | Class II | Terminated |
| D-1320-2016 | 04-20-2016 | Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 5183-0906-48 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 20 | Class II | Terminated |
| D-1310-2016 | 04-20-2016 | Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0827-77 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 100 | Class II | Terminated |
| D-1302-2016 | 04-20-2016 | Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0803-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 10 | Class II | Terminated |
| D-1336-2016 | 04-20-2016 | Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0961-72 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 2665 | Class II | Terminated |
| D-1312-2016 | 04-20-2016 | Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060 , NDC 45183-0865-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 675 | Class II | Terminated |
| D-1283-2016 | 04-20-2016 | Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0502-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 20 | Class II | Terminated |
| D-1329-2016 | 04-20-2016 | Ketamine 2 mg/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 45183-0938-68 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 150 | Class II | Terminated |
| D-1276-2016 | 04-20-2016 | Promethazine 25 mg 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 45183-0187-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 485 | 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-1298-2016 | 04-20-2016 | Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0766-03 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 468 | Class II | Terminated |
| D-1281-2016 | 04-20-2016 | Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0322-78 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 25 | Class II | Terminated |
| D-1341-2016 | 04-20-2016 | Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0989-41 | Lack of Assurance of Sterility | Pharmakon Pharmaceuticals, Inc. / 10 | Class II | Terminated |
