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 July 04, 2025 and include a total of 16930 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0220-2019 | 10-26-2018 | deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27. Package NDCs: 11084-010-40; 11084-010-27; 11084-010-12; 11084-010-20; 11084-010-05; 11084-010-01; 11084-010-55; 11084-010-96; 11084-010-66 | CGMP Deviations: Product was released to market prior to microbiological testing. | S.C. Johnson Professional / 869 cases | Class II | Terminated |
| D-0485-2019 | 10-26-2018 | Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 UPC 343598637525 ---- NDC 43598-637-52 Package NDCs: 43598-635-52; 43598-635-10; 43598-636-52; 43598-636-10; 43598-637-52; 43598-637-10; 3435986375 | Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL). | Dr. Reddy's Laboratories, Inc. / 2770 bags; 277 selling units | Class I | Terminated |
| D-0245-2019 | 10-26-2018 | Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00 | Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing. | RemedyRepack Inc. / 1 vial | Class III | Terminated |
| D-0221-2019 | 10-26-2018 | Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441. | CGMP Deviations: Product was released to market prior to microbiological testing. | S.C. Johnson Professional / 258 cases | Class II | Terminated |
| D-0127-2019 | 10-24-2018 | Irbesartan Bulk Active Pharmaceutical Ingredient. | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. | Aurobindo Pharma Limited (Unit I) / 1724.8 kgs. | Class II | Terminated |
| D-0217-2019 | 10-23-2018 | Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560. | Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser. | Janssen Pharmaceuticals, Inc. / 1,777 cartons | Class II | Terminated |
| D-0218-2019 | 10-23-2018 | Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day Regimen per pouch, packaged in a) 6 Veridate Tablet Dispensers and 6 Refill pouches (NDC 504-58-178-28) per carton (NDC 50458-178-06); and b) 12 Veridate Tablet Dispenser Refills (NDC 50458-178-12) per carton (NDC 50458-178-12), Clinic Package, , Rx Only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560. | Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser. | Janssen Pharmaceuticals, Inc. / a) 3,956 cartons; b) 1 carton | Class II | Terminated |
| D-0128-2019 | 10-22-2018 | Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01 | Failed Dissolution Specifications: OOS resultsduring routine stability testing | Boehringer Ingelheim Pharmaceuticals, Inc. / 1,380 100-count bottles | Class II | Terminated |
| D-0133-2019 | 10-19-2018 | Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 360 bags | Class II | Terminated |
| D-0132-2019 | 10-19-2018 | Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 20 syringes | Class II | Terminated |
| D-0135-2019 | 10-19-2018 | Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 300 bags | Class II | Terminated |
| D-0134-2019 | 10-19-2018 | Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 300 bags | Class II | Terminated |
| D-0131-2019 | 10-19-2018 | Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 1,360 bags | Class II | Terminated |
| D-0129-2019 | 10-19-2018 | Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01 | Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing. | Teva Pharmaceuticals USA / 53,451 bottles | Class II | Terminated |
| D-0277-2019 | 10-19-2018 | children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5. Package NDCs: 56062-106-08 | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. | Taro Pharmaceuticals U.S.A., Inc. / 8328 bottles | Class II | Terminated |
| D-0278-2019 | 10-19-2018 | children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4. | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. | Taro Pharmaceuticals U.S.A., Inc. / | Class II | Terminated |
| D-0276-2019 | 10-19-2018 | Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2. | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. | Taro Pharmaceuticals U.S.A., Inc. / 12,432 bottles | Class II | Terminated |
| D-0239-2019 | 10-18-2018 | Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684 | Presence of precipitate | Promise Pharmacy LLC / N/A | Class III | Terminated |
| D-0415-2019 | 10-18-2018 | GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00 | Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing. | H J Harkins Company Inc dba Pharma Pac / 84, 5 ml bottles | Class II | Terminated |
| D-0237-2019 | 10-17-2018 | Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0229-2019 | 10-17-2018 | Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0233-2019 | 10-17-2018 | Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0232-2019 | 10-17-2018 | Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0235-2019 | 10-17-2018 | Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0231-2019 | 10-17-2018 | Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0238-2019 | 10-17-2018 | Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30 count (NDC 69761-222-30) vials, Rx Only, Qualgen, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0230-2019 | 10-17-2018 | Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0234-2019 | 10-17-2018 | Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0225-2019 | 10-17-2018 | Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0236-2019 | 10-17-2018 | Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0226-2019 | 10-17-2018 | Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0228-2019 | 10-17-2018 | Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0227-2019 | 10-17-2018 | Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0246-2019 | 10-15-2018 | Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA | Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine | Zero Xtreme USA / 16 bottles | Class II | Terminated |
| D-0094-2019 | 10-15-2018 | Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31 Package NDCs: 23155-216-31; 3231552163 | Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle | Heritage Pharmaceuticals, Inc. / 2,789 Units | Class II | Terminated |
| D-0222-2019 | 10-15-2018 | Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10 Package NDCs: 36000-033-10 | Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots. | Baxter Healthcare Corporation / 402,165 vials | Class III | Terminated |
| D-0083-2019 | 10-11-2018 | HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80. Package NDCs: 54838-502-80 | CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities. | Lannett Company, Inc. / 8,324 bottles | Class II | Terminated |
| D-0087-2019 | 10-09-2018 | Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11 Package NDCs: 68180-943-11 | Defective Container: Repetitive complaints received indicating pump not working. | Lupin Pharmaceuticals Inc. / 6,752 bottles | Class III | Terminated |
| D-0118-2019 | 10-09-2018 | Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0024-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 1,055 bottles | Class II | Terminated |
| D-0121-2019 | 10-09-2018 | Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879NDC 61096-0023-1 and Tester NDC 61096-1023-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 1,473 bottles | Class II | Terminated |
| D-0116-2019 | 10-09-2018 | Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0030-1 and Tester NDC 61096-1030-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 2,956 bottles | Class II | Terminated |
| D-0105-2019 | 10-09-2018 | Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0035-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 1,558 bottles | Class II | Terminated |
| D-0122-2019 | 10-09-2018 | ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0038-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 2,837 bottles | Class II | Terminated |
| D-0126-2019 | 10-09-2018 | Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0004-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 3634 bottles | Class II | Terminated |
| D-0109-2019 | 10-09-2018 | MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0014-1 and Tester NDC 61096-1014 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 2,301 bottles | Class II | Terminated |
| D-0108-2019 | 10-09-2018 | Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0034-1 and Tester NDC 61096-1034-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 1,284 bottles | Class II | Terminated |
| D-0124-2019 | 10-09-2018 | Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0027-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 919 bottles | Class II | Terminated |
| D-0119-2019 | 10-09-2018 | Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0006-1 and Tester NDC 61096-1006-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 3,896 bottles | Class II | Terminated |
| D-0110-2019 | 10-09-2018 | Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0012-1 and Tester NDC 61096-1012-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 731 bottles | Class II | Terminated |
| D-0125-2019 | 10-09-2018 | Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0039-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 2,595 bottles | Class II | Terminated |
| D-0106-2019 | 10-09-2018 | Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0025-1 and Tester NDC 61096-1025-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 830 bottles | Class II | Terminated |
| D-0111-2019 | 10-09-2018 | AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0003-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 4,153 bottles | Class II | Terminated |
| D-0120-2019 | 10-09-2018 | PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0031-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 647 bottles | Class II | Terminated |
| D-0107-2019 | 10-09-2018 | Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0033-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 2,054 bottles | Class II | Terminated |
| D-0115-2019 | 10-09-2018 | TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879NDC 61096-0007-1. and Tester NDC 61096-1007-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 1,307 bottles | Class II | Terminated |
| D-0114-2019 | 10-09-2018 | SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0001-1 and Tester NDC 6196-1001-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 5,393 bottles | Class II | Terminated |
| D-0113-2019 | 10-09-2018 | DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0005-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 1,465 bottles | Class II | Terminated |
| D-0123-2019 | 10-09-2018 | Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0017-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 857 bottles | Class II | Terminated |
| D-0112-2019 | 10-09-2018 | Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0002-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 2,565 bottles | Class II | Terminated |
| D-0117-2019 | 10-09-2018 | Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0032-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 3,531 bottles | Class II | Terminated |
| D-0216-2019 | 10-08-2018 | 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045 | Lack of Assurance of Sterility; bags have the potential to leak | ICU Medical Inc / 2,580,448 bags | Class II | Terminated |
| D-0215-2019 | 10-08-2018 | 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045 | Lack of Assurance of Sterility; bags have the potential to leak | ICU Medical Inc / 372,912 bags | Class II | Terminated |
| D-0414-2019 | 10-08-2018 | Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10 | Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing. | Akorn, Inc. / 149,159 5mL bottles | Class II | Terminated |
| D-0092-2019 | 10-05-2018 | Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60 Package NDCs: 43386-069-60 | Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis | LUPIN SOMERSET / 2712 60-ml bottles | Class II | Terminated |
| D-0219-2019 | 10-05-2018 | Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99 Package NDCs: 51267-890-99; 51267-890-07 | Container packaging defect. | Orexigen Therapeutics, Inc. / 18,895 bottles | Class III | Terminated |
| D-0249-2019 | 10-05-2018 | Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071. | Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing. | Amerigen Pharmaceuticals Inc. / 5,232 bottles: a) 4,146 bottles; b) 1,086 bottles | Class III | Terminated |
| D-0012-2019 | 10-03-2018 | Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15 Package NDCs: 69097-126-05; 69097-126-15; 69097-127-05; 69097-127-15; 69097-128-05; 69097-128-15; 3690971281 | Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition. | InvaGen Pharmaceuticals, Inc. / 2880 bottles | Class III | Terminated |
| D-0252-2019 | 10-03-2018 | Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-275-02 | Microbial Contamination of Non-Sterile Products | Silver Star Brands / 95 bottles | Class I | Terminated |
| D-0255-2019 | 10-03-2018 | Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-204-02 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Silver Star Brands / 247 bottles | Class II | Terminated |
| D-0251-2019 | 10-03-2018 | Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02 | Microbial Contamination of Non-Sterile Products | Silver Star Brands / 67 bottles | Class I | Terminated |
| D-0253-2019 | 10-03-2018 | Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-105-59 | Microbial Contamination of Non-Sterile Products | Silver Star Brands / 53 bottles | Class I | Terminated |
| D-0254-2019 | 10-03-2018 | Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-151-59 | Microbial Contamination of Non-Sterile Product | Silver Star Brands / 931 bottles | Class I | Terminated |
| D-0256-2019 | 10-03-2018 | Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Silver Star Brands / 247 bottles | Class II | Terminated |
| D-0015-2019 | 10-03-2018 | Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-6729-03. Package NDCs: 0409-6730-11; 0409-6730-13; 0409-6730-50; 0409-6730-60; 0409-6729-41; 0409-6729-23; 0409-6729-21; 0409-6729-03; 0409-6729-31; 0409-6729-09; 0409-6729-11; 0409-6729-24; 0409-4121-01; 0409-4121-50; 0409-2050-01; 0409-2050-20; 0409-3164-01; 0409-3164-12; 0409-5239-01; 0409-5239-60 | Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection. | Pfizer Inc. / 94,752 bags | Class II | Terminated |
| D-0011-2019 | 10-02-2018 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90. Package NDCs: 59746-283-30; 59746-283-90; 59746-283-01; 59746-283-05; 59746-283-10; 59746-283-03; 59746-284-30; 59746-284-90; 59746-284-01; 59746-284-05; 59746-284-10; 59746-284-03 | Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets. | Jubilant Cadista Pharmaceuticals, Inc. / 158,466 bottles | Class II | Terminated |
| D-0223-2019 | 09-28-2018 | Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356 | Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date | Tailor Made Compounding / 10,280 Vials | Class II | Terminated |
| D-0244-2019 | 09-27-2018 | Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02 | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing | Teva Pharmaceuticals USA / 1,362 vials | Class II | Terminated |
| D-0088-2019 | 09-26-2018 | Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059. | CGMP deviations | GLAXOSMITHKLINE NEBRASKA / 5,548,673 bottles | Class II | Terminated |
| D-0243-2019 | 09-25-2018 | Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376 NDC 99999-9969-51 | Labeling Not Elsewhere Classified: Misbranding. | Right Value Drug Stores, Inc. / 180 capsules | Class III | Terminated |
| D-0240-2019 | 09-25-2018 | Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0104-55 | Labeling Not Elsewhere Classified: Misbranding. | Right Value Drug Stores, Inc. / 6580 capsules | Class III | Terminated |
| D-0241-2019 | 09-25-2018 | Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0018-74 | Labeling Not Elsewhere Classified: Misbranding. | Right Value Drug Stores, Inc. / 8240 capsules | Class III | Terminated |
| D-0242-2019 | 09-25-2018 | Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054. NDC 99999-9970-88 | Labeling Not Elsewhere Classified: Misbranding. | Right Value Drug Stores, Inc. / 660 capsules | Class III | Terminated |
| D-0130-2019 | 09-25-2018 | Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450 | Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent. | RXQ Compounding LLC / 395 vials | Class II | Terminated |
| D-1215-2018 | 09-25-2018 | Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India. Package NDCs: 36000-045-01; 36000-046-24; 36000-047-24; 36000-048-24 | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Baxter Healthcare Corporation / 523,896 bags | Class III | Terminated |
| D-0007-2019 | 09-21-2018 | Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India Package NDCs: 43598-431-44; 43598-431-30; 43598-431-60 | Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing. | Dr. Reddy's Laboratories, Inc. / 35020 tubes | Class II | Terminated |
| D-0001-2019 | 09-21-2018 | Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side. Package NDCs: 0093-5416-01; 0093-5417-01; 0093-5417-19; 0093-5417-84; 0093-5419-01; 0093-5419-19; 0093-5419-84; 0093-5376-01; 0093-5376-19; 0093-5376-84; 0093-5377-01; 0093-5377-19; 0093-5377-84 | Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing. | Teva Pharmaceuticals USA / 313 bottles | Class II | Terminated |
| D-0010-2019 | 09-20-2018 | Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2 | CGMP Deviations; rejected product was used to manufacture final bulk lot | Pfizer Inc. / 7777 bottles | Class II | Terminated |
| D-0095-2019 | 09-20-2018 | Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11 | Lack of assurance of sterility: loss of container integrity. | Pfizer Inc. / 71,075 vials | Class II | Terminated |
| D-0082-2019 | 09-20-2018 | Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96 | Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing. | Teva Pharmaceuticals USA / 1,373 60-count cartons | Class II | Terminated |
| D-0281-2019 | 09-19-2018 | Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11 Package NDCs: 0832-0540-11; 0832-0541-11; 0832-0541-10; 0832-0542-11; 0832-0542-10 | Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product. | Upsher Smith Laboratories, Inc. / 29,080 bottles | Class II | Terminated |
| D-0280-2019 | 09-19-2018 | Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11 Package NDCs: 0832-0540-11; 0832-0541-11; 0832-0541-10; 0832-0542-11; 0832-0542-10 | Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product. | Upsher Smith Laboratories, Inc. / 44,764 bottles | Class II | Terminated |
| D-0005-2019 | 09-19-2018 | Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-0106-01 Package NDCs: 0069-0106-01 | Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button. | Pfizer Inc. / 12,416 vials | Class II | Terminated |
| D-0016-2019 | 09-18-2018 | Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets. Manufactured by Laboratories Leon Farma S.A., Spain, for Xiromed, LLC., Florham Park, NJ 07932. Product of Spain NDC 70700-116-85 (I unit x 28 tablets 70700-116-84) Package NDCs: 70700-116-85; 70700-116-84 | Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion. | Xiromed LLC / 40064 3x28 units | Class III | Terminated |
| D-0009-2019 | 09-17-2018 | robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10. | Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily." | Endo Pharmaceuticals, Inc. / 2,856 bottles | Class I | Terminated |
| D-0017-2019 | 09-17-2018 | treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850. Marketed by: Deerfield, IL 60015 USA. Bar Code DCSKit-59148-10Tabs-01 | Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit. | Otsuka Pharmaceutical Development & Commercialization, Inc. / 17325 kits | Class III | Terminated |
| D-0018-2019 | 09-17-2018 | treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs Abilify Tablets 10 mg (14 day supply) plus 1 Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850 USA Marketed by: Lundbleck, Deerfield, IL 60015 USA Bar Code VialKit-59148-10Tabs-02 | Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit. | Otsuka Pharmaceutical Development & Commercialization, Inc. / 4738 kits | Class III | Terminated |
| D-0247-2019 | 09-17-2018 | SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA Package NDCs: 53329-083-21; 53329-083-92; 53329-083-93; 53329-083-94; 53329-081-93 | Microbial Contamination of Non-Sterile Product | Medline Industries Inc / 994,756 tubes | Class II | Terminated |
| D-0103-2019 | 09-12-2018 | Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52 Package NDCs: 55111-688-52 | Failed Impurities/Degradation Specifications: OOS for unknown impurities. | Dr. Reddy's Laboratories, Inc. / 59,468 vials | Class III | Terminated |
| D-1211-2018 | 09-12-2018 | Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90 Package NDCs: 31722-595-30; 31722-595-90; 31722-595-31; 31722-595-32; 31722-596-30; 31722-596-90; 31722-596-31; 31722-596-32 | Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg. | Hetero Labs, Ltd. - Unit III / 5,424 bottles | Class III | Terminated |
| D-0104-2019 | 09-12-2018 | Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. N+ and NOVAPLUS are registered trademarks of Vizient, Inc. NDC 43598-331-11 Package NDCs: 43598-331-11 | Failed Impurities/Degradation Specifications: OOS for unknown impurities. | Dr. Reddy's Laboratories, Inc. / 10,530 vials | Class III | Terminated |
