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-0108-2018 | 11-28-2017 | Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73. Package NDCs: 0093-1172-01; 0093-1172-10; 0093-1174-01; 0093-1174-10; 0093-4125-73; 0093-4125-74; 0093-4127-73; 0093-4127-74 | Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities. | Teva Pharmaceuticals USA / 42,384 bottles | Class III | Terminated |
| D-0100-2018 | 11-28-2017 | Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0. | CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity. | EAI-JR286 INC / 5,355 tubes | Class II | Terminated |
| D-0097-2018 | 11-21-2017 | Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068 Package NDCs: 68180-294-07; 68180-294-03; 68180-294-09; 68180-294-06; 68180-295-06; 68180-295-09; 68180-295-03; 68180-296-03; 68180-296-06; 68180-296-09; 68180-297-06; 68180-297-09; 68180-297-03; 3681802950 | Failed Dissolution Specification | Lupin Pharmaceuticals Inc. / 111,648 units | Class III | Terminated |
| D-0101-2018 | 11-20-2017 | Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534 Package NDCs: 68382-097-16; 68382-097-01; 68382-097-05; 68382-097-10; 68382-097-06; 68382-098-06; 68382-098-16; 68382-098-01; 68382-098-05; 68382-098-10; 68382-099-06; 68382-099-16; 68382-099-01; 68382-099-05; 68382-099-10; 68382-001-06; 68382-001-16; 68382-001-01; 68382-001-05; 68382-001-10 | Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets | Zydus Pharmaceuticals USA Inc / 19812 bottles | Class II | Terminated |
| D-0336-2018 | 11-20-2017 | Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559 | CGMP Deviations: Market complaints related to "gritty texture". | Glenmark Pharmaceuticals Inc., USA / 5136 tubes | Class II | Terminated |
| D-0125-2018 | 11-20-2017 | Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28 | Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active. | Teva Pharmaceuticals USA / 5,374 blister cards/28 tablets | Class II | Terminated |
| D-0470-2018 | 11-19-2017 | Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA | Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil. | www.blankterrmall.com / 10 boxes | Class I | Terminated |
| D-0092-2018 | 11-17-2017 | Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09 Package NDCs: 68180-485-03; 68180-485-09; 68180-485-02; 68180-486-09; 68180-486-02; 68180-486-03; 68180-487-09; 68180-487-02; 68180-487-03; 68180-488-09; 68180-488-02; 68180-488-03 | Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle. | Lupin Limited / N/A | Class II | Terminated |
| D-0192-2018 | 11-16-2017 | Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 30 droptainers | Class II | Terminated |
| D-0185-2018 | 11-16-2017 | Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 2,535 vials | Class II | Terminated |
| D-0174-2018 | 11-16-2017 | Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 1,203 vials | Class II | Terminated |
| D-0203-2018 | 11-16-2017 | Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 479 vials | Class II | Terminated |
| D-0176-2018 | 11-16-2017 | Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 2,239 vials | Class II | Terminated |
| D-0184-2018 | 11-16-2017 | Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 696 vials | Class II | Terminated |
| D-0161-2018 | 11-16-2017 | Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 15,700 capsules | Class II | Terminated |
| D-0164-2018 | 11-16-2017 | Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 490 jars | Class II | Terminated |
| D-0170-2018 | 11-16-2017 | Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 20 jars | Class II | Terminated |
| D-0173-2018 | 11-16-2017 | Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 2,239 tablets | Class II | Terminated |
| D-0166-2018 | 11-16-2017 | Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 1,380 jars | Class II | Terminated |
| D-0189-2018 | 11-16-2017 | QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 126 vials | Class II | Terminated |
| D-0187-2018 | 11-16-2017 | PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 3,000 tablets | Class II | Terminated |
| D-0175-2018 | 11-16-2017 | Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 6,414 vials | Class II | Terminated |
| D-0167-2018 | 11-16-2017 | Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 3,280 jars | Class II | Terminated |
| D-0204-2018 | 11-16-2017 | Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 3612 vials | Class II | Terminated |
| D-0193-2018 | 11-16-2017 | Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 3,000 tablets | Class II | Terminated |
| D-0200-2018 | 11-16-2017 | T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 173 vials | Class II | Terminated |
| D-0206-2018 | 11-16-2017 | 7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 90 capsules | Class II | Terminated |
| D-0169-2018 | 11-16-2017 | Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 90 capsules | Class II | Terminated |
| D-0182-2018 | 11-16-2017 | Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 40 jars | Class II | Terminated |
| D-0168-2018 | 11-16-2017 | Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 300 jars | Class II | Terminated |
| D-0205-2018 | 11-16-2017 | Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 5786 vials | Class II | Terminated |
| D-0196-2018 | 11-16-2017 | Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 157 vials | Class II | Terminated |
| D-0199-2018 | 11-16-2017 | Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 94 vials | Class II | Terminated |
| D-0162-2018 | 11-16-2017 | Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 80 vials | Class II | Terminated |
| D-0190-2018 | 11-16-2017 | QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 122 vials | Class II | Terminated |
| D-0188-2018 | 11-16-2017 | Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 300 jars | Class II | Terminated |
| D-0183-2018 | 11-16-2017 | Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 970 capsules | Class II | Terminated |
| D-0186-2018 | 11-16-2017 | Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 963 bags | Class II | Terminated |
| D-0180-2018 | 11-16-2017 | Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 1,009 vials | Class II | Terminated |
| D-0202-2018 | 11-16-2017 | Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 81 droptainers | Class II | Terminated |
| D-0179-2018 | 11-16-2017 | Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 30 jars | Class II | Terminated |
| D-0195-2018 | 11-16-2017 | Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 597 vials | Class II | Terminated |
| D-0191-2018 | 11-16-2017 | QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 129 vials | Class II | Terminated |
| D-0171-2018 | 11-16-2017 | Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 100 jars | Class II | Terminated |
| D-0197-2018 | 11-16-2017 | Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 898 vials | Class II | Terminated |
| D-0177-2018 | 11-16-2017 | Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 7,862 vials | Class II | Terminated |
| D-0163-2018 | 11-16-2017 | Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 22,520 capsules | Class II | Terminated |
| D-0181-2018 | 11-16-2017 | Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 596 vials | Class II | Terminated |
| D-0194-2018 | 11-16-2017 | Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 80 cartridges | Class II | Terminated |
| D-0172-2018 | 11-16-2017 | Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 300 jars | Class II | Terminated |
| D-0207-2018 | 11-16-2017 | 7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 90 capsules | Class II | Terminated |
| D-0178-2018 | 11-16-2017 | Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 2,274 vials | Class II | Terminated |
| D-0165-2018 | 11-16-2017 | Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 4,530 jars | Class II | Terminated |
| D-0201-2018 | 11-16-2017 | Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 297 droptainers | Class II | Terminated |
| D-0198-2018 | 11-16-2017 | Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 235 vials | Class II | Terminated |
| D-0827-2018 | 11-13-2017 | 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10. | Lack of Assurance of Sterility | Fresenius Medical Care Renal Therapies Group, LLC / 25,356 1 liter bags | Class II | Terminated |
| D-0107-2018 | 11-13-2017 | Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013 | Failed Impurities/Degradation Specifications | Elite Laboratories Inc. / 1264 bottles | Class III | Terminated |
| D-0124-2018 | 11-11-2017 | Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India | Superpotent | Renaissance Lakewood, LLC / 24,569 bags | Class III | Terminated |
| D-0135-2018 | 11-10-2017 | Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577 | Failed Stability Specifications | Bayer HealthCare Pharmaceuticals, Inc. / 104,128 HDPE bottles | Class III | Terminated |
| D-0573-2018 | 11-10-2017 | Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10 Package NDCs: 43066-150-10; 43066-360-20 | Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged | Baxter Healthcare Corporation / 35,628 single-dose containers | Class I | Terminated |
| D-0551-2018 | 11-09-2017 | GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04 | Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans | Kareway Products Inc / 60,000 bottles | Class I | Terminated |
| D-0096-2018 | 11-09-2017 | Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05 | Failed Tablet/Capsule Specifications; potential presence of broken tablets. | Teva Pharmaceuticals USA / 3,870 bottles | Class II | Terminated |
| D-0098-2018 | 11-09-2017 | Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01 | Failed Dissolution Specifications. | Mayne Pharma Inc / 11,364 bottles | Class II | Terminated |
| D-0128-2018 | 11-08-2017 | Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by Perrigo, Allegan, MI 49010, NDC 70085-151-01 | Microbial Contamination of Non-Sterile Products | L. Perrigo Company / 19,944 Cartons (24 tablets each) | Class II | Terminated |
| D-0093-2018 | 11-06-2017 | Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA. Package NDCs: 0641-0367-21; 0641-0367-25; 0641-6145-01; 0641-6145-25; 0641-6146-01; 0641-6146-10; 0641-6146-25 | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). | West-Ward Pharmaceuticals Corp. / 16,157 shelf packs | Class III | Terminated |
| D-0094-2018 | 11-06-2017 | Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA. Package NDCs: 0641-0367-21; 0641-0367-25; 0641-6145-01; 0641-6145-25; 0641-6146-01; 0641-6146-10; 0641-6146-25 | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). | West-Ward Pharmaceuticals Corp. / 1,896 shelf packs | Class III | Terminated |
| D-0127-2018 | 11-06-2017 | Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249 | Superpotent | Claris Lifesciences Inc / | Class III | Terminated |
| D-0090-2018 | 11-03-2017 | Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2 oz Balm(NDC 69804-014-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com | GMP Deviations: inadequate manufacturing control processes | Ridge Properties, LLC / N/A | Class II | Terminated |
| D-0089-2018 | 11-03-2017 | Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC 69804-024-14), 2 oz Liquid Gel (NDC 69804-024-15), 4 oz Liquid Gel (NDC 69804-024-16) bottles, Manufactured by Pain Relief Naturally, www.Naturally HL.com | GMP Deviations: inadequate manufacturing control processes | Ridge Properties, LLC / N/A | Class II | Terminated |
| D-0087-2018 | 11-03-2017 | Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 69804-018-11), and 4 oz Gel (NDC 69804-018-12) jars, Manufactured by Pain Relief Naturally, www.Naturally HL.com | GMP Deviations: inadequate manufacturing control processes | Ridge Properties, LLC / N/A | Class II | Terminated |
| D-0088-2018 | 11-03-2017 | Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08), 1 oz Spray (NDC 69804-015-07), 2 oz Spray (NDC 69804-015-01) and 4 oz Spray (NDC 69804-015-04) bottles, Manufactured by Pain Relief Naturally, www.Naturally HL.com | GMP Deviations: inadequate manufacturing control processes | Ridge Properties, LLC / N/A | Class II | Terminated |
| D-0230-2018 | 11-03-2017 | bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05 | Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing. | Mylan Pharmaceuticals Inc. / 1,414/500 count bottles | Class III | Terminated |
| D-0086-2018 | 11-03-2017 | Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06), 1 oz Balm (NDC 69804-008-05), 2 oz Balm(NDC 69804-008-02), and 4 oz Balm(NDC 69804-008-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com | GMP Deviations: inadequate manufacturing control processes | Ridge Properties, LLC / N/A | Class II | Terminated |
| D-0072-2018 | 10-30-2017 | Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023 | Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle | Dr. Reddy's Laboratories, Inc. / 23402 cases | Class III | Terminated |
| D-0220-2018 | 10-30-2017 | ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC 71030-0003-10 and NDC 71030-0003-20, and b) 25-count cartons, NDC 71030-0003-21 and NDC 71030-0003-12, Rx Only, PharMEDium Services, LLC, 913 N. Davis Ave, Cleveland, MS, Code 2R3304. | Subpotent Drug | Pharmedium Services, LLC / 5002 syringes | Class II | Terminated |
| D-0082-2018 | 10-30-2017 | Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06 Package NDCs: 59746-122-06; 59746-122-10; 59746-121-06; 59746-121-10 | Marketed without an approved NDA/ANDA: Bottles were released prior to final approval. | Jubilant Cadista Pharmaceuticals, Inc. / 744 bottles | Class III | Terminated |
| D-0152-2018 | 10-27-2017 | Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20 Package NDCs: 76045-211-00; 76045-211-20; 76045-001-00; 76045-001-20; 76045-002-00; 76045-002-10; 76045-003-00; 76045-003-20 | Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL | Fresenius Kabi USA, LLC / 203136 syringes | Class I | Terminated |
| D-0069-2018 | 10-25-2017 | Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. | Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results. | Teva Pharmaceuticals USA / 140,993 bottles | Class II | Terminated |
| D-0079-2018 | 10-25-2017 | Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 | cGMP Deviations: lack of quality assurance at the API manufacturer. | Fagron, Inc / 934 grams | Class II | Terminated |
| D-0071-2018 | 10-24-2017 | Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA | Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag | Ace Surgical Supply Co., Inc. / 200 vials (25 mislabeled vials) | Class II | Terminated |
| D-0091-2018 | 10-24-2017 | Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01 Package NDCs: 68084-044-11; 68084-044-01; 68084-044-65; 68084-045-11; 68084-045-01; 68084-046-11; 68084-046-01; 68084-047-11; 68084-047-01 | Presence of Foreign Tablets/Capsules. | Amerisource Health Services / 74 cartons (cartons of 100 individual unit doses) | Class II | Terminated |
| D-0150-2018 | 10-20-2017 | diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977 Package NDCs: 59762-1061-1; 59762-1061-2 | SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent | Pfizer Inc. / 183437 bottles | Class I | Terminated |
| D-0151-2018 | 10-20-2017 | Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30 | SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent | Pfizer Inc. / 1972 bottles | Class II | Terminated |
| D-0077-2018 | 10-19-2017 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612.. Package NDCs: 0023-9211-03; 0023-9211-05; 0023-9211-10; 0023-9211-15 | Failed Impurities/Degradation Specifications. | Allergan Sales, LLC / 715,041 bottles | Class III | Terminated |
| D-0062-2018 | 10-19-2017 | fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 116 bags | Class II | Terminated |
| D-0059-2018 | 10-19-2017 | SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 1248 syringes | Class II | Terminated |
| D-0063-2018 | 10-19-2017 | fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 20 bags inside rigid translucent plastic cases (CADD) | Class II | Terminated |
| D-0064-2018 | 10-19-2017 | morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / a) 60 bag inside rigid translucent plastic case (CADD) b) 238 bag | Class II | Terminated |
| D-0060-2018 | 10-19-2017 | HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 128 syringes | Class II | Terminated |
| D-0061-2018 | 10-19-2017 | HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 60 bags | Class II | Terminated |
| D-0068-2018 | 10-19-2017 | ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 487 syringes | Class II | Terminated |
| D-0066-2018 | 10-19-2017 | PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 1221 syringes | Class II | Terminated |
| D-0065-2018 | 10-19-2017 | oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 450 bags | Class II | Terminated |
| D-0067-2018 | 10-19-2017 | Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30 | Lack Of Assurance Of Sterility. | SCA Pharmaceuticals, LLC / 76 bags | Class II | Terminated |
| D-0078-2018 | 10-19-2017 | Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03 Package NDCs: 0023-3205-02; 0023-3205-03; 0023-3205-05; 0023-3205-08 | Failed Impurities/Degradation Specifications. | Allergan Sales, LLC / 153,616 bottles | Class III | Terminated |
| D-0052-2018 | 10-17-2017 | Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01. | Failed Dissolution Specifications: Low out of specification results for dissolution. | Teva Pharmaceuticals USA / 58,292 bottles | Class III | Terminated |
| D-0080-2018 | 10-13-2017 | Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40 | Superpotent drug: out of specification result for potency | PharMEDium Services, LLC. / 499 syringes | Class II | Terminated |
| D-0056-2018 | 10-13-2017 | Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01. | Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection. | Sanofi-Aventis U.S. LLC / 422 vials | Class III | Terminated |
| D-0075-2018 | 10-12-2017 | Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01. | Labeling: Incorrect or Missing Package Insert. | Genzyme Corporation / 9,343 single dose vials | Class III | Terminated |
| D-0099-2018 | 10-12-2017 | Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47 Package NDCs: 31722-574-47 | Presence of foreign substance (screw) | Hetero Labs, Ltd. - Unit III / 4050 bottles | Class II | Terminated |
