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-1018-2019 | 03-13-2019 | fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 180 bags | Class II | Terminated |
| D-1017-2019 | 03-13-2019 | fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 360 bags | Class II | Terminated |
| D-1028-2019 | 03-13-2019 | Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 800 syringes | Class II | Terminated |
| D-1016-2019 | 03-13-2019 | HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 2400 syringes | Class II | Terminated |
| D-1029-2019 | 03-13-2019 | Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 550 syringes | Class II | Terminated |
| D-1032-2019 | 03-13-2019 | Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 1850 syringes | Class II | Terminated |
| D-1023-2019 | 03-13-2019 | Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 22900 syringes | Class II | Terminated |
| D-1019-2019 | 03-13-2019 | Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 1125 bags | Class II | Terminated |
| D-1031-2019 | 03-13-2019 | Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe, NDC: 42852-739-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 1440 syringes | Class II | Terminated |
| D-1027-2019 | 03-13-2019 | 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 1980 syringes | Class II | Terminated |
| D-1010-2019 | 03-13-2019 | 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. / 3,200 bottles | Class III | Terminated |
| D-1126-2019 | 03-12-2019 | 15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027, UPC 8 54582 00120 3. | Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. | MSM Nutraceuticals, LLC / 5000 30 ml bottles | Class II | Terminated |
| D-1127-2019 | 03-12-2019 | Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51 fl oz., Manufactured by: MSM Nutraceuticals, LLC, UPC 8 54582 00119 7. | Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. | MSM Nutraceuticals, LLC / 200 15ml bottles | Class II | Terminated |
| D-1011-2019 | 03-12-2019 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10 | Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature. | Akorn Inc / 15,322 10 ml bottles | Class II | Terminated |
| D-1128-2019 | 03-12-2019 | Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufactured by: MSM Nutraceuticals, LLC , UPC 8 54582 00118 0 | Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. | MSM Nutraceuticals, LLC / 200 15 ml Bottles | Class II | Terminated |
| D-1129-2019 | 03-12-2019 | Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology Drive, Deerfield BEach, FL 33441 SKU#182 UPC 00854582001036 | Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. | MSM Nutraceuticals, LLC / 500 30 mL bottles | Class II | Terminated |
| D-0032-2021 | 03-12-2019 | Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90 | CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API. | Direct Rx / 33 bottles | Class II | Terminated |
| D-1008-2019 | 03-11-2019 | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8. Package NDCs: 50914-7720-8 | Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured. | Iso-Tex Diagnostics, Inc / 54 syringes | Class II | Terminated |
| D-1006-2019 | 03-11-2019 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0093-3008-93 Package NDCs: 0093-3008-19; 0093-3008-93; 0093-3009-19; 0093-3009-93 | Subpotent Drug. | Teva Pharmaceuticals USA / 7,081 bottles | Class III | Terminated |
| D-0341-2021 | 03-08-2019 | Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90 Package NDCs: 43063-854-60; 43063-854-90; 43063-0854-90 | CGMP deviation: Product found to contain trace amounts of NMBA | PD-Rx Pharmaceuticals, Inc. / 576 bottles | Class II | Terminated |
| D-1012-2019 | 03-07-2019 | Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little Remedies Infant Fever Reducer (acetaminophen 150mg) 2 fl. oz. bottle, Little Remedies Saline Spray/Drops (sodium chloride) 0.5 fl oz., Little Remedies Gripe Water (zingiber officinale (Ginger) Root Extract 5mg, Foeniculum vulgare (Fennel) Seed Extract 4 mg) 2 fl. oz bottle., Little Remedies Gas Relief Drops (simethicone emulsion USP 66.7 mg and simethicone 20 mg) 1 fl. oz., Boudreaux's Butt Paste (zinc oxide 16%) 2 oz. ointment,. Distributed by Medtech Products Inc. Tarrytown, NY, a Prestige Consumer Healthcare Company. UPC 7 56184 00007 6. | Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit. | Medtech Products, Inc. / 4,716 kits | Class II | Terminated |
| D-1055-2019 | 03-07-2019 | Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-125-90 | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products | Rising Pharmaceuticals, Inc. / 42,016 bottles | Class II | Ongoing |
| D-0991-2019 | 03-07-2019 | Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61. | Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing. | Boehringer Ingelheim Pharmaceuticals, Inc. / 112 folding cartons | Class III | Terminated |
| D-1054-2019 | 03-07-2019 | Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 ---- NDC 52343-124-90 | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products | Rising Pharmaceuticals, Inc. / 35,281 bottles | Class II | Ongoing |
| D-1053-2019 | 03-07-2019 | Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-123-90 | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products | Rising Pharmaceuticals, Inc. / 37,410 bottles | Class II | Ongoing |
| D-1052-2019 | 03-07-2019 | Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30 | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products | Rising Pharmaceuticals, Inc. / 30,530 bottles | Class II | Ongoing |
| D-1051-2019 | 03-06-2019 | Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807. | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified. | Preferred Pharmaceuticals, Inc / 530 | Class II | Terminated |
| D-1047-2019 | 03-06-2019 | Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01) | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. | American Health Packaging / 3337 cartons | Class II | Terminated |
| D-1001-2019 | 03-06-2019 | Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40. Package NDCs: 43598-258-11; 43598-259-40; 43598-389-57 | Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance. | Dr. Reddy's Laboratories, Inc. / 5,755 vials | Class II | Terminated |
| D-1044-2019 | 03-05-2019 | Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | AVKARE Inc. / N/A | Class II | Terminated |
| D-1135-2019 | 03-05-2019 | LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz is labeled as LEOPARD Miracle of Honey, UPC 8 699415 912859, Manufactured in Turkey, www leopardhoneytr.com. | Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. | USA LESS Inc. / 83 boxes | Class I | Terminated |
| D-1045-2019 | 03-05-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | AVKARE Inc. / N/A | Class II | Terminated |
| D-1046-2019 | 03-05-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | AVKARE Inc. / N/A | Class II | Terminated |
| D-0994-2019 | 03-04-2019 | ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons per case, Petra Hygienic Systems, Concord, ON L4K 4RS/ Reno, NV 89511, NDC 42326-550-01, UPC 0 65936 10335 5. | Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products. | Petra Hygienic Systems Int Ltd / 58 cases | Class III | Terminated |
| D-1083-2019 | 03-04-2019 | Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side. | CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API). | H J Harkins Company Inc dba Pharma Pac / 300 tablets | Class II | Terminated |
| D-1050-2019 | 03-01-2019 | Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-579-54 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Legacy Pharmaceutical Packaging LLC / 2,497,856 bottles | Class II | Ongoing |
| D-0992-2019 | 03-01-2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb. | Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. | Apotex Inc. / 82,705 cartons | Class II | Completed |
| D-1048-2019 | 03-01-2019 | Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Legacy Pharmaceutical Packaging LLC / 456,732 bottles | Class II | Ongoing |
| D-1049-2019 | 03-01-2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-578-54 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Legacy Pharmaceutical Packaging LLC / 2,851,284 bottles | Class II | Ongoing |
| D-1075-2019 | 03-01-2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected. | Legacy Pharmaceutical Packaging LLC / 179,544 30-count bottles | Class II | Terminated |
| D-1820-2019 | 03-01-2019 | Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33 | Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples. | American Health Packaging / 13,229 cartons | Class II | Terminated |
| D-0990-2019 | 03-01-2019 | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Package NDCs: 42291-633-01; 42291-633-50; 42291-634-01; 42291-634-50; 42291-635-01 | Failed Dissolution Specifications | AVKARE Inc. / a) 2947 and b) 3379 | Class III | Terminated |
| D-1043-2019 | 02-28-2019 | Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-702-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India Package NDCs: 31722-700-30; 31722-700-60; 31722-700-90; 31722-700-05; 31722-700-10; 31722-701-30; 31722-701-60; 31722-701-90; 31722-701-05; 31722-701-10; 31722-702-30; 31722-702-60; 31722-702-90; 31722-702-05; 31722-702-10 | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient | Camber Pharmaceuticals Inc / 683,641 bottles | Class II | Ongoing |
| D-1042-2019 | 02-28-2019 | Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-701-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India Package NDCs: 31722-700-30; 31722-700-60; 31722-700-90; 31722-700-05; 31722-700-10; 31722-701-30; 31722-701-60; 31722-701-90; 31722-701-05; 31722-701-10; 31722-702-30; 31722-702-60; 31722-702-90; 31722-702-05; 31722-702-10 | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient | Camber Pharmaceuticals Inc / 69712 bottles | Class II | Ongoing |
| D-1041-2019 | 02-28-2019 | Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India Package NDCs: 31722-700-30; 31722-700-60; 31722-700-90; 31722-700-05; 31722-700-10; 31722-701-30; 31722-701-60; 31722-701-90; 31722-701-05; 31722-701-10; 31722-702-30; 31722-702-60; 31722-702-90; 31722-702-05; 31722-702-10 | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient | Camber Pharmaceuticals Inc / 351,732 bottles | Class II | Ongoing |
| D-1116-2019 | 02-28-2019 | LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 121,668 bottles | Class II | Ongoing |
| D-1115-2019 | 02-28-2019 | LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count (NDC: 13668-409-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 476,340 bottles | Class II | Ongoing |
| D-1114-2019 | 02-28-2019 | LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 133,992 bottles | Class II | Ongoing |
| D-0519-2019 | 02-28-2019 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD | Failed Dissolution Specifications; 9-monthstability timepoint | Jubilant Cadista Pharmaceuticals, Inc. / a) 3,072 bottles; b) 2,688 bottles | Class III | Terminated |
| D-1118-2019 | 02-28-2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC: 13668-117-90) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 172,296 bottles | Class II | Ongoing |
| D-1119-2019 | 02-28-2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 173,760 bottles | Class II | Ongoing |
| D-1117-2019 | 02-28-2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / N/A | Class II | Ongoing |
| D-0517-2019 | 02-26-2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01. Package NDCs: 68180-422-01 | Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities. | Lupin Pharmaceuticals Inc. / 674,628 bottles | Class III | Terminated |
| D-1004-2019 | 02-25-2019 | Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07 | Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. | Macleods Pharma Usa Inc / 140,589 bottles | Class II | Terminated |
| D-1003-2019 | 02-25-2019 | Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07 | Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. | Macleods Pharma Usa Inc / 93227 bottles | Class II | Terminated |
| D-1005-2019 | 02-25-2019 | Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-130-07 | Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. | Macleods Pharma Usa Inc / 134495 bottles | Class II | Terminated |
| D-1009-2019 | 02-22-2019 | Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per packet, 28-count capsules per box, MAT XI S.G Co., LTD, Head office: J29 Vo Thi Sau Street, Thong Nhat Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Manufactory: 148/9 Tan Tien Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Product distribution franshise by GoLean Detox Enterprise 002677155-A Malaysia, www.matxisg.com, UPC 8 938510 909013. | Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the US. The presence of sibutramine and phenolphthalein in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall. | Golean Detox US / 37 boxes | Class I | Terminated |
| D-0993-2019 | 02-22-2019 | Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10. | Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point. | Akorn, Inc. / 51,456 bottles | Class II | Terminated |
| D-1066-2019 | 02-22-2019 | Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05. Package NDCs: 67877-450-30; 67877-450-60; 67877-450-01; 67877-450-05; 67877-450-10; 67877-450-33; 67877-450-38 | Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing. | Ascend Laboratories LLC / 3,072 bottles | Class II | Terminated |
| D-1101-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 5ml injectable | Class II | Terminated |
| D-1107-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 3 prescriptions, 5ml injectable | Class II | Terminated |
| D-1105-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 2 prescriptions, 5ml injection | Class II | Terminated |
| D-1092-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 3 prescriptions 10, 9, ml injection | Class II | Terminated |
| D-1093-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 13 prescription 5, 6, 9, 10 ml injection | Class II | Terminated |
| D-1090-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 64 prescriptions 5, 10, 6 mL injections | Class II | Terminated |
| D-1098-2019 | 02-21-2019 | PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 25 prescriptions 10, 9, ml injectable | Class II | Terminated |
| D-1110-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 5ml injection | Class II | Terminated |
| D-1096-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 2 prescription 5, 6.5 ml injection | Class II | Terminated |
| D-1102-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 9ml injection | Class II | Terminated |
| D-1089-2019 | 02-21-2019 | HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 4 prescriptions 9 & 10ml injectable | Class II | Terminated |
| D-1097-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 3 prescription 5, 10 ml injection | Class II | Terminated |
| D-1109-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 5ml | Class II | Terminated |
| D-1106-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 18ml injection | Class II | Terminated |
| D-1091-2019 | 02-21-2019 | PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) 6ml (d) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 5 prescriptions 5,10, 6, 9 ml injectable | Class II | Terminated |
| D-1094-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 9 prescriptions 10, 9ml injection | Class II | Terminated |
| D-1099-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription 9ml injectable | Class II | Terminated |
| D-1104-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription 9ml injection | Class II | Terminated |
| D-1103-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 16.6-0.55 MG-11.1 MCG/ML* INJECTABLE, 10 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 2 pre4scriptions 10 ml injections | Class II | Terminated |
| D-1088-2019 | 02-21-2019 | ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 6 prescriptions 10ml dropper bottle | Class II | Terminated |
| D-1086-2019 | 02-21-2019 | SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription 20ml solution | Class II | Terminated |
| D-1108-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 15-0.25MG-6MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 5ml injection | Class II | Terminated |
| D-0996-2019 | 02-21-2019 | Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37 Package NDCs: 62175-270-37; 62175-270-41; 62175-271-37; 62175-271-41; 62175-272-37; 62175-272-41 | Failed Dissolution Specifications | Lannett Company Inc. / 14,448 bottles | Class III | Terminated |
| D-1087-2019 | 02-21-2019 | DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 12 prescriptions | Class II | Terminated |
| D-1100-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 . | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 1 prescription, 9ml injectable | Class II | Terminated |
| D-1095-2019 | 02-21-2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. | Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy / 2 prescription 5ml injection | Class II | Terminated |
| D-1040-2019 | 02-21-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10 | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. | Macleods Pharma Usa Inc / 9695 bottles | Class II | Terminated |
| D-0520-2019 | 02-20-2019 | Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent 32 Fl. Oz. (1 QT) 946 mL bottle, Distributed By: Discount Drug Mart 211 Commerce Drive, Medina, Ohio 44256 NDC 53943-871-45 UPC 0-93351-12758-8 | Cross Contamination: Presence of IPA in finished product. | Vi-Jon, Inc. / 6756 32 oz bottles | Class II | Terminated |
| D-1584-2019 | 02-19-2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories. Package NDCs: 68001-314-00; 68001-314-08; 68001-315-00; 68001-315-08; 68001-316-00; 68001-316-08 | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results. | American Health Packaging / 14,360 bottles | Class III | Terminated |
| D-0518-2019 | 02-19-2019 | Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 292-6772- 17 Great Oaks Blvd., San Jose, CA 95119. NDC: 70360-007-35. | Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride. | Leiter's Enterprises, Inc. / 569 vials | Class II | Terminated |
| D-0516-2019 | 02-19-2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071 | Failed dissolution specifications | Amerigen Pharmaceuticals Inc. / a) 2,413 bottles b) 3,355 bottles | Class III | Terminated |
| D-1065-2019 | 02-15-2019 | Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31 | Subpotent Drug. | Heritage Pharmaceuticals, Inc. / 11888 units | Class II | Terminated |
| D-0821-2020 | 02-14-2019 | Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704 | Presence of Particulate Matter: Particulates observed in vials release for dispensing. | McGuff Compounding Pharmacy Services, Inc. / N/A | Class II | Terminated |
| D-0989-2019 | 02-13-2019 | Maeng Da Kratom, packaged in a) 20 count capsules (UPC 00859667007149), b) 60 count capsules (UPC 00859667007156), c) 150 count capsules (UPC 00859667007163) , Sunstone Organics Springfield, Oregon 97473, 541-972-3327. | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Todd Holiday dba Sunstone Organics / N/A | Class I | Terminated |
| D-0987-2019 | 02-13-2019 | White Vein Kratom, packaged in a) 25 gram powder (UPC 00859667007316), b) 50 gram powder (UPC 00859667007323), c) 100 gram powder (UPC 00859667007330), Sunstone Organics Springfield, Oregon 97473, 541-972-3327. | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Todd Holiday dba Sunstone Organics / 250 Kilograms | Class I | Terminated |
| D-0986-2019 | 02-13-2019 | Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gram powder (UPC 00859667007125), c) 100 gram powder (UPC 00859667007132), Sunstone Organics Springfield, Oregon 97473, 541-972-3327. | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Todd Holiday dba Sunstone Organics / 800 kilograms | Class I | Terminated |
| D-0988-2019 | 02-13-2019 | White Vein Kratom, packaged in a) 20 count capsules (UPC 00859667007347), b) 60 count capsules (UPC 00859667007354), c) 150 count capsules (UPC 00859667007361), Sunstone Organics Springfield, Oregon 97473 541-972-3327. | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Todd Holiday dba Sunstone Organics / N/A | Class I | Terminated |
| D-0512-2019 | 02-13-2019 | Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09 Package NDCs: 45802-401-09 | Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing. | Perrigo New York, Inc. / 12252 bottles | Class III | Terminated |
| D-0513-2019 | 02-13-2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA. Package NDCs: 68180-467-09; 68180-467-07; 68180-467-01; 68180-467-03; 68180-467-05; 68180-468-07; 68180-468-01; 68180-468-03; 68180-468-05; 68180-468-09; 68180-469-07; 68180-469-01; 68180-469-03; 68180-469-05; 68180-469-09 | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results. | Lupin Pharmaceuticals Inc. / 44,640 bottles | Class III | Terminated |
| D-0506-2019 | 02-13-2019 | Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505 | Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing | Mylan Pharmaceuticals Inc. / 8,159 bottles | Class III | Terminated |
| D-1111-2019 | 02-08-2019 | Indian Herb Paste (a dietary supplement) Ingredients: Galangal, Indian Paint, Yellow Dock & Licorice in an alloy of Life-Line tm and Zinc Chloride in 6 dram vials, McDaniel Life-Line LLC, Dimmitt, TX | Unapproved new drug | McDaniel Life-Line LLC / 150 vials | Class II | Terminated |
