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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0412-2015 | 02-11-2015 | DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow, KY, 42141, NDC 53150-317-01. | Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL | Mylan Institutional LLC / 936 vials | Class III | Terminated |
| D-0395-2015 | 02-10-2015 | Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1. | Failed Dissolution Specifications | Actavis Elizabeth LLC / 42 bottles | Class II | Terminated |
| D-0419-2015 | 02-06-2015 | Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0073-02, UPC 3 11917 15114 4. | Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point. | Tarmac Products, Inc. / 78,591 bottles | Class II | Terminated |
| D-1825-2015 | 01-28-2015 | Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-107-50 | Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). | Pharmedium Services, LLC / 663 bags | Class I | Terminated |
| D-1826-2015 | 01-28-2015 | PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (80 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-156-50 | Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). | Pharmedium Services, LLC / 84 bags | Class I | Terminated |
| D-1828-2015 | 01-28-2015 | PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (40 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-149-50 | Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). | Pharmedium Services, LLC / 120 bags | Class I | Terminated |
| D-1824-2015 | 01-28-2015 | Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-181-50 | Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). | Pharmedium Services, LLC / 100 bags | Class I | Terminated |
| D-1823-2015 | 01-28-2015 | Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50 | Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). | Pharmedium Services, LLC / 20 bags | Class I | Terminated |
| D-1821-2015 | 01-28-2015 | PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-171-50 | Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). | Pharmedium Services, LLC / 240 bags | Class I | Terminated |
| D-1827-2015 | 01-28-2015 | PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (240 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-236-50 | Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). | Pharmedium Services, LLC / 48 bags | Class I | Terminated |
| D-0385-2015 | 01-28-2015 | Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 . | Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests. | Akorn, Inc. / 23,449 jars | Class II | Terminated |
| D-1822-2015 | 01-28-2015 | PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-169-50 | Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair). | Pharmedium Services, LLC / 24 bags | Class I | Terminated |
| D0384-2015 | 01-26-2015 | Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection. | Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. | AnazaoHealth Corporation / 51 vials | Class II | Terminated |
| D-0977-2015 | 01-25-2015 | EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00417 4. | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug. | Detox Transforms / 150 bottles | Class I | Terminated |
| D-0979-2015 | 01-25-2015 | AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00418 1. | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug. | Detox Transforms / 150 bottles | Class I | Terminated |
| D-0980-2015 | 01-25-2015 | BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00406 8. | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug. | Detox Transforms / 173 bottles | Class I | Terminated |
| D-0981-2015 | 01-25-2015 | iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00408 2. | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug. | Detox Transforms / 200 bottles | Class I | Terminated |
| D-0978-2015 | 01-25-2015 | iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4. | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug. | Detox Transforms / 175 bottles | Class I | Terminated |
| D-0413-2015 | 01-23-2015 | Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10 | Subpotent Drug and Failed Impurities/Degradation Specifications | Mylan Institutional LLC / 78,090 vials | Class III | Terminated |
| D-0483-2015 | 01-23-2015 | KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49 Package NDCs: 0409-3793-19; 0409-3793-01; 0409-3793-25; 0409-3795-19; 0409-3795-01; 0409-3795-25; 0409-3796-19; 0409-3796-01; 0409-3796-25; 0409-3796-49 | Crystallization | Hospira Inc. / HOSPIRA = 4,339,500 vials. NOVAPLUS = 341,100 vials | Class II | Terminated |
| D-0482-2015 | 01-23-2015 | KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49 Package NDCs: 0409-3793-19; 0409-3793-01; 0409-3793-25; 0409-3795-19; 0409-3795-01; 0409-3795-25; 0409-3796-19; 0409-3796-01; 0409-3796-25; 0409-3795-49 | Crystallization | Hospira Inc. / HOSPIRA = 13,720,475 vials, NOVAPLUS = 1,528,500 vials | Class II | Terminated |
| D-0394-2015 | 01-21-2015 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC 41616-219-90, UPC 3 41616 21990 6. | Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution. | Sun Pharma Global Fze / 5322 bottles | Class II | Terminated |
| D-0386-2015 | 01-21-2015 | Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86 | Failed Dissolution Specifications: 6 month time point. | Sun Pharma Global Fze / 3263 bottles | Class II | Terminated |
| D-0969-2015 | 01-20-2015 | 0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02 | Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area. | Hospira Inc. / 661,128 containers | Class I | Terminated |
| D-0869-2016 | 01-20-2015 | Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901. | Non-Sterility: Product tested positive for bacterial contamination. | Pacifico National, Inc. dba AmEx Pharmacy / 45 syringes | Class I | Terminated |
| D-0870-2016 | 01-20-2015 | Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901. | Non-Sterility: Product tested positive for bacterial contamination. | Pacifico National, Inc. dba AmEx Pharmacy / 836 syringes | Class I | Terminated |
| D-724-2016 | 01-13-2015 | fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3174, PharMEDium | Subpotent Drug | Pharmedium Services, LLC / 500 syringes | Class I | Terminated |
| D-723-2016 | 01-13-2015 | fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium. | Subpotent Drug | Pharmedium Services, LLC / 180 syringes | Class I | Terminated |
| D-1086-2015 | 01-12-2015 | Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: One lot exceeded the mechanical peel specification | Noven Pharmaceuticals, Inc. / 125,340 Patches | Class II | Terminated |
| D-0562-2016 | 01-08-2015 | 5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd. 328 Wener Rd, Xihu, Hangzhou, Zhejiang, China | Subpotent Drug | Freedom Pharmaceuticals Inc / (a) 2 containers, (b) 32 containers, (c) 48 containers | Class III | Terminated |
| D-0434-2015 | 01-06-2015 | Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73. | Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals. | Wallcur Incorporated / 18,657 Bags | Class I | Terminated |
| D-0430-2015 | 01-06-2015 | Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose) Package NDCs: 68084-214-11; 68084-214-01 | Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules | American Health Packaging / 2284 cartons (100 individual unit doses per carton) | Class II | Terminated |
| D-0339-2015 | 01-02-2015 | Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, 877-550-5059 | Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015". | SCA Pharmaceuticals / 972 syringes | Class II | Terminated |
| D-0379-2015 | 12-31-2014 | Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four 6 g vials, 100 mL, Distributed by: Valeant Pharmaceuticals North America, Bridgewater, NJ 08807 USA, NDC 0187-0007-14. | Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull. | Valeant Pharmaceuticals North America LLC / 2,428 vials | Class II | Terminated |
| D-0383-2015 | 12-30-2014 | Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8. | Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup. | Taro Pharmaceuticals U.S.A., Inc. / 36,684 Bottles | Class II | Terminated |
| D-0355-2015 | 12-26-2014 | Gentamicin various strength in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0342-2015 | 12-26-2014 | Aztreonam 1 gram in normal saline | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0365-2015 | 12-26-2014 | Dopamine various strengths in dextrose | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0367-2015 | 12-26-2014 | Thiamine 100 mg/ ml vials | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0360-2015 | 12-26-2014 | Tigecycline various strengths in normal saline | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0364-2015 | 12-26-2014 | Dobutamine various strengths in dextrose | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0369-2015 | 12-26-2014 | Magnesium sulfate various strengths in sodium chloride | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0361-2015 | 12-26-2014 | Acyclovir various strengths in normal saline | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0348-2015 | 12-26-2014 | Piperacillin/ tazobactam various strength in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0366-2015 | 12-26-2014 | Folic acid 1 mg/ 0.2 ml pre-drawn syringes | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0370-2015 | 12-26-2014 | Deferoxamine various strengths in normal saline | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class III | Terminated |
| D-0349-2015 | 12-26-2014 | Vancomycin various strengths in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0372-2015 | 12-26-2014 | Diphenhydramine 50 mg/ml vials | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0351-2015 | 12-26-2014 | Meropenem various strengths in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0345-2015 | 12-26-2014 | Ceftazidime various strength in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0347-2015 | 12-26-2014 | Ertapenem various strength in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0358-2015 | 12-26-2014 | Levofloxacin various strengths in normal saline | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0343-2015 | 12-26-2014 | Cefepime various strengths in normal saline | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0373-2015 | 12-26-2014 | Immune globulin g human various strengths | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0357-2015 | 12-26-2014 | Ceftriaxone various strengths in normal saline | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0374-2015 | 12-26-2014 | L-cysteine various strengths | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0368-2015 | 12-26-2014 | Ranitidine various strengths in syringes | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0350-2015 | 12-26-2014 | Cefuroxime various strengths in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0356-2015 | 12-26-2014 | Daptomycin various strengths in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0346-2015 | 12-26-2014 | Imipenem/ cilastatin various strength in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0340-2015 | 12-26-2014 | Liposomal Amphotericin B 130 mg in dextrose bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0375-2015 | 12-26-2014 | Total parenteral nutrition various strengths | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0344-2015 | 12-26-2014 | Cefoxitin various strength in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0353-2015 | 12-26-2014 | Cefazolin various strengths in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0362-2015 | 12-26-2014 | Milrinone various strengths in dextrose | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0352-2015 | 12-26-2014 | Nafcillin various strengths in sterile water for injection bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0341-2015 | 12-26-2014 | Amikacin various strength in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0363-2015 | 12-26-2014 | Caspofungin various strengths in normal saline | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0359-2015 | 12-26-2014 | Linezolid various strengths in dextrose | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0354-2015 | 12-26-2014 | Tobramycin various strengths in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0371-2015 | 12-26-2014 | Dehydrated alcohol vials | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0380-2015 | 12-23-2014 | Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446. Package NDCs: 0338-6046-48; 0338-6045-37 | Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam. | Baxter Healthcare Corp. / 31,130 bags | Class II | Terminated |
| D-0325-2015 | 12-23-2014 | Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05 Package NDCs: 68382-247-01; 68382-247-05; 68382-091-01 | Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. | Zydus Pharmaceuticals USA Inc / 19,536 units | Class II | Terminated |
| D-0381-2015 | 12-23-2014 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30 Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25; 0409-1511-97; 0409-1511-98; 0409-0501-97; 0409-0501-98; 0409-0010-97; 0409-0010-98 | Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron. | Hospira Inc. / 126,075 vials | Class II | Terminated |
| D-0334-2015 | 12-22-2014 | 0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11 | Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port. | Hospira Inc. / 30840 bags | Class II | Terminated |
| D-0331-2015 | 12-22-2014 | ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 | Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol. | Qualitest Pharmaceuticals / a) 3936 bottles; b) 84420 bottles | Class III | Terminated |
| D-1207-2015 | 12-19-2014 | SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc. | Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis. | Bethel Nutritional Consulting, Inc / UNKNOWN | Class I | Terminated |
| D-0376-2015 | 12-19-2014 | 3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878-3130-04), Rx Only, Manufactured for 3M ESPE Dental Products, St. Paul, MN 55144 | Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box.. | 3M Company/3m Espe Dental Products / 19,728 tubes | Class III | Terminated |
| D-0424-2015 | 12-19-2014 | B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040. | Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss | Bethel Nutritional Consulting, Inc / UNKNOWN | Class II | Terminated |
| D-469-2015 | 12-17-2014 | Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm , Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 2 bags | Class I | Terminated |
| D-446-2015 | 12-17-2014 | Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 4 bags | Class I | Terminated |
| D-451-2015 | 12-17-2014 | Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% without Ca, Trophamine 12g, Dextrose 20g, compound vol: 200 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 5 bags | Class I | Terminated |
| D-466-2015 | 12-17-2014 | Bayshore Medical Center (TX) 5% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 5%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 3 bags | Class I | Terminated |
| D-442-2015 | 12-17-2014 | Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 4 bags | Class I | Terminated |
| D-444-2015 | 12-17-2014 | Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamine 2% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 1 bag | Class I | Terminated |
| D-453-2015 | 12-17-2014 | Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, Dextrose 10%, Additives: heparin PF 0.5 unit(s)/mL, Calcium Gluconate 600mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 6 bags | Class I | Terminated |
| D-467-2015 | 12-17-2014 | Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM, Trophamine 4g/dL, Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 5 bags | Class I | Terminated |
| D-0328-2015 | 12-17-2014 | Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN | Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli | Tropichem Research Labs, Inc. / 24,348 / 2 oz. bottles | Class II | Terminated |
| D-440-2015 | 12-17-2014 | Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 2 bags | Class I | Terminated |
| D-450-2015 | 12-17-2014 | Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 4 bags | Class I | Terminated |
| D-456-2015 | 12-17-2014 | Truman Medical Center Lakewood (MO) Trophamine UAC Solution, Trophamine 3.2g, compound vol: 100 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 5 bags | Class I | Terminated |
| D-465-2015 | 12-17-2014 | Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 3 bags | Class I | Terminated |
| D-468-2015 | 12-17-2014 | Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Trophamine 5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46 mEq/mL, 750mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 2 bags | Class I | Terminated |
| D-458-2015 | 12-17-2014 | Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 4 bags | Class I | Terminated |
| D-454-2015 | 12-17-2014 | St Lukes East Lees Summit (MO) Protein Bag,Trophamine 5g, Dextrose 10%, Additives: Calcium Gluconate 4.65mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 6 bags | Class I | Terminated |
| D-457-2015 | 12-17-2014 | Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, Additives: Calcium Gluconate 0.46mEq/mL, 7mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 10 bags | Class I | Terminated |
| D-437-2015 | 12-17-2014 | University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box. each container is lined with a polystyrene insert; CAPS, Allentown, PA | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 20 bags | Class I | Terminated |
| D-470-2015 | 12-17-2014 | Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 12 bags | Class I | Terminated |
| D-464-2015 | 12-17-2014 | Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10%, Additives: heparin PF 62.5 units, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 6 bags | Class I | Terminated |
| D-439-2015 | 12-17-2014 | Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 8 bags | Class I | Terminated |
