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-0363-2018 | 08-22-2017 | Toothette Oral Care Daily Oral Cleansing Kit Petite Size with Antiseptic Oral Rinse. Contains: 10 Petite Size Oral Swabs, individually wrapped, 1.5 fl oz/44ml bottle of Antiseptic Oral Rinse, .5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6006 UPC (01)00618029800053 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 637 cases | Class II | Terminated |
| D-0383-2018 | 08-22-2017 | Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 1 Suction toothbrush with sodium bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6571 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 8466 Cases | Class II | Terminated |
| D-0398-2018 | 08-22-2017 | Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Suction Handle, Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6904 UPC 6 18029 83008 1 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 6130 Cases | Class II | Terminated |
| D-0361-2018 | 08-22-2017 | Toothette Oral Care Short Term Oral Care System with Perox-A-Mint solution, Contains 1.5 fl oz/44 ml bottle of Perox-A-Mint solution, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpaste, 1 Ultra-Soft Toothbrush, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6002-D UPC (01)00618029821461 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 849 cases | Class II | Terminated |
| D-0369-2018 | 08-22-2017 | Toothette Oral Care Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml Antiseptic Oral Rinse, 0.7 fl oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6113 UPC (01)00618029820990 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 879 cases | Class II | Terminated |
| D-0405-2018 | 08-22-2017 | Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6964 UPC 6 18029 83075 3 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 3928 Cases | Class II | Terminated |
| D-0389-2018 | 08-22-2017 | Toothette Oral Care Q Care & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Perox-A-Mint solution, 10 Suction Oral Swab packages with Perox-A-Mint solution, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6602 UPC 6 18029 84116 2 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 2408 Cases | Class II | Terminated |
| D-0366-2018 | 08-22-2017 | Toothette Oral Care Perox-A- Mint solution, Oral Debriding Agent 8 fl oz/237 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6060 UPC (01)00618029800152 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 945 cases | Class II | Terminated |
| D-0395-2018 | 08-22-2017 | Q.CareOral Cleansing & Suctioning System q2. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6802 UPC 6 18029 84120 9 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 2970 Cases | Class II | Terminated |
| D-0379-2018 | 08-22-2017 | Toothette Oral Care Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer, Contains 2 Suctino Swabs with sodium bicarbonate, 0.25 fl oz/7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6513 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 42,628 cases | Class II | Terminated |
| D-0375-2018 | 08-22-2017 | Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6414 UPC 6 18029 84138 4 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 13,041 cases | Class II | Terminated |
| D-0373-2018 | 08-22-2017 | Q CARE q4 Oral Cleaning & Suctioning System Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6404 UPC 6 18029 84133 9 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 2,194 cases | Class II | Terminated |
| D-0378-2018 | 08-22-2017 | Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untreated Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint- solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6502 UPC 6 18029 80060 2 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 852 cases | Class II | Terminated |
| D-0380-2018 | 08-22-2017 | Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs with sodium, bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 10 Applicator Swabs, .5 oz/14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6550 6 18029 80065 7 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 11194 CASES | Class II | Terminated |
| D-0400-2018 | 08-22-2017 | Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Suction Oral Swab packages with Alcohol-Free Mouthwash, 4 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6914 UPC 6 18029 83017 3 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 82072 Cases | Class II | Terminated |
| D-0381-2018 | 08-22-2017 | Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs with sodium, bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 2 Packages of 1 Suction Toothbrush with sodium bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 10 Applicator Swabs, .5 oz/14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6552 UPC 6 18029 82115 7 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 5303 Cases | Class II | Terminated |
| D-0362-2018 | 08-22-2017 | Independent Care System Corinz, Contains: 1.5 fl oz bottle Corinz Mouthwash, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpast, 1 Ultra-Soft toothbrush. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6004 UPC 6 18029 82148 5 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 94 cases | Class II | Terminated |
| D-0411-2018 | 08-22-2017 | Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Contains: Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium Bicarbonate. 1 Bottle of 3M Skin and Nasal Antiseptic (Povidone-Iodine Solution 5%w/w (0.5%available iodine) USP) Patient Preoperative Skin Preparation 0.14 fl oz (4ml), 4 sterile swabs. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9010 UPC 6 18029 79139 9 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / | Class II | Terminated |
| D-0358-2018 | 08-22-2017 | Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution. Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, .3 oz./9g tube of Sodium Bicarbonate Mouthpaste, I Ultra-Soft Toothbrush, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6001, UPC (01)00618029800039 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 2,429 cases | Class II | Terminated |
| D-0396-2018 | 08-22-2017 | Q.CARE Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Toothbrush packages with Antiplaque solution. 4 Suction Oral Swab packages with Perox-A-Mint solution. 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6804 UPC 6 18029 84121 6 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 5085 Cases | Class II | Terminated |
| D-0388-2018 | 08-22-2017 | Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2, Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Packages Suction Oral Swab with sodium bicarbonate, Perox-A-Mint solution and Mouth Moisturizer, , 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6594-S UPC 6 18029 82134 1 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 20 Cases | Class II | Terminated |
| D-0404-2018 | 08-22-2017 | Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6924 UPC 6 18029 83033 3 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 16639 Cases | Class II | Terminated |
| D-0357-2018 | 08-22-2017 | Toothette Oral Care Antiseptic Oral Rinse 1.5 fl.oz/44 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6122 UPC 6 18029 80079 4 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 4,061 cases | Class II | Terminated |
| D-0386-2018 | 08-22-2017 | Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2, Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Packages Suction Oral Swab with sodium bicarbonate, Perox-A-Mint solution and Mouth Moisturizer, 6 Packages Suction Oral Swab with sodium bicarbonate, Alcohol Free Mouthwash and Mouth Moisturizer, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6592-S UPC 6 18029 82133 1 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 25 Cases | Class II | Terminated |
| D-0410-2018 | 08-22-2017 | Skin antisepsis and oral cleansing. Contains Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium Bicarbonate. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9009 UPC 6 18029 79140 5 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 150 Cases | Class II | Terminated |
| D-0390-2018 | 08-22-2017 | Toothette Oral Care Suction Swabs with Perox-A-Mint solution. Contains 2 Suction Swabs with sodium bicarbonate, 0.25 fl oz/ 7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6613 | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Sage Products Inc / 4650 Cases | Class II | Terminated |
| D-0084-2018 | 08-22-2017 | No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th Street, Brooklyn, NY 11232. UPC 5842109854239 | Marketed Without an Approved NDA/ANDA | Shata Trading, Inc. / 96 foil packages | Class II | Terminated |
| D-1167-2017 | 08-22-2017 | HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial) Package NDCs: 0409-2552-11; 0409-2552-01; 0409-3356-11; 0409-3356-01; 0409-2540-11; 0409-2540-01; 0409-3365-11; 0409-3365-01; 0409-3365-10; 0409-1283-03; 0409-1283-31; 0409-1312-03; 0409-1312-30; 0409-1304-03; 0409-1304-31 | Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. | Pfizer Inc. / 115,370 vials | Class II | Terminated |
| D-1140-2017 | 08-22-2017 | Ninjacof (Chlophedianol HCL 12.5 mg and Pyrilamine Maleate 12.5 mg) Oral Solution, 16 fl. oz. (473 mL), Cotton Candy Flavor, Manufactured for: Centurion Labs, LLC Birmingham, AL 35243 --- NDC 23359-032-16 Package NDCs: 23359-032-16; 23359-032-10; 23359-032-04 | Microbial contamination of Non-sterile Products; potential B. cepacia contamination | Centurion Labs, LLC / 4149 bottles | Class II | Terminated |
| D-1168-2017 | 08-22-2017 | Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04 Package NDCs: 0409-3375-14; 0409-3375-04; 0409-1443-14; 0409-1443-04 | Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. | Pfizer Inc. / 98,050 vials | Class II | Terminated |
| D-1137-2017 | 08-18-2017 | Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8 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; 6838209906 | Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets | Zydus Pharmaceuticals USA Inc / 44800 bottles | Class II | Terminated |
| D-1139-2017 | 08-17-2017 | Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16 | Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance | VistaPharm, Inc. / 3084 bottles | Class III | Terminated |
| D-0148-2018 | 08-17-2017 | All Sterile Products within expiry | Lack of Assurance of Sterility . | Vital Rx, Inc. dba Atlantic Pharmacy and Compounding / 61 Products | Class II | Terminated |
| D-0224-2018 | 08-16-2017 | Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85, Manufactured by PharmaTech LLC, Davie, FL | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination | Pharmatech LLC / Unknown | Class II | Terminated |
| D-0227-2018 | 08-16-2017 | Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FL | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination | Pharmatech LLC / Unknown | Class II | Terminated |
| D-0225-2018 | 08-16-2017 | Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, Manufactured by PharmaTech LLC, Davie, FL | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination | Pharmatech LLC / Unknown | Class II | Terminated |
| D-0226-2018 | 08-16-2017 | Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59 ; ALSO LABELED AS Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09; Manufactured by PharmaTech LLC, Davie, FL | Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination | Pharmatech LLC / Unknown | Class II | Terminated |
| D-1124-2017 | 08-15-2017 | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00 | Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples. | Amphastar Pharmaceuticals, Inc. / 637,810 vials | Class II | Terminated |
| D-1151-2017 | 08-15-2017 | B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 45 vials | Class II | Terminated |
| D-1157-2017 | 08-15-2017 | Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 6 bottles | Class II | Terminated |
| D-1154-2017 | 08-15-2017 | L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 5 vials | Class II | Terminated |
| D-1161-2017 | 08-15-2017 | BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 200 syringes | Class II | Terminated |
| D-1150-2017 | 08-15-2017 | Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 5 vials | Class II | Terminated |
| D-1152-2017 | 08-15-2017 | Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 7 vials | Class II | Terminated |
| D-1156-2017 | 08-15-2017 | Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 6 bottles | Class II | Terminated |
| D-1148-2017 | 08-15-2017 | Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 10 vials | Class II | Terminated |
| D-1147-2017 | 08-15-2017 | Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 30 vials | Class II | Terminated |
| D-1146-2017 | 08-15-2017 | PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 82 vials | Class II | Terminated |
| D-1159-2017 | 08-15-2017 | Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 644 vials | Class II | Terminated |
| D-1149-2017 | 08-15-2017 | G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 3 vials | Class II | Terminated |
| D-1160-2017 | 08-15-2017 | Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 2,334 syringes | Class II | Terminated |
| D-1158-2017 | 08-15-2017 | Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 20 vials | Class II | Terminated |
| D-1155-2017 | 08-15-2017 | MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 5 vials | Class II | Terminated |
| D-1153-2017 | 08-15-2017 | Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA. | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. / 5 vials | Class II | Terminated |
| D-1118-2017 | 08-11-2017 | Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940 Package NDCs: 55289-791-07; 55289-791-14; 55289-791-15; 55289-791-21; 55289-791-28; 55289-791-30; 55289-791-60 | Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test . | PD-Rx Pharmaceuticals, Inc. / 3440 bottles | Class III | Terminated |
| D-1125-2017 | 08-10-2017 | Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054, NDC 60432-065-00. | Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product. | Morton Grove Pharmaceuticals, Inc. / 7332 bottles | Class II | Terminated |
| D-0136-2018 | 08-10-2017 | Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0143-2018 | 08-10-2017 | Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0903-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0141-2018 | 08-10-2017 | Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0140-2018 | 08-10-2017 | Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88887-6795-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0142-2018 | 08-10-2017 | Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, , Fenton, MO --- NDC: 88890-0334-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0139-2018 | 08-10-2017 | HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0138-2018 | 08-10-2017 | Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0144-2018 | 08-10-2017 | Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0137-2018 | 08-10-2017 | Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-0333-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0145-2018 | 08-10-2017 | Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-7536-01 | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / N/A | Class II | Terminated |
| D-0129-2018 | 08-10-2017 | Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15 | Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data. | Premier Pharmacy Labs Inc / 1610 syringes | Class II | Terminated |
| D-0102-2018 | 08-07-2017 | Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16 | Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg. | International Laboratories, Inc. / 82056 bottles | Class I | Terminated |
| D-1129-2017 | 08-04-2017 | Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09 | Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label. | Degasa Sa De Cv / 720 bottles | Class II | Terminated |
| D-1164-2017 | 08-04-2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-25. | Failed Dissolution Specifications | Pfizer Inc. / 11,790 bottles | Class III | Terminated |
| D-1163-2017 | 08-04-2017 | Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-20. | Failed Dissolution Specifications | Pfizer Inc. / 14,712 bottles | Class III | Terminated |
| D-1086-2017 | 08-04-2017 | Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01 Package NDCs: 59676-303-00; 59676-303-01; 59676-304-00; 59676-304-01; 59676-310-00; 59676-310-01; 59676-310-02; 59676-302-00; 59676-302-01; 59676-340-00; 59676-340-01; 59676-312-00; 59676-312-04; 59676-320-00; 59676-320-04 | Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials. | Amgen, Inc. / 175,632 vials | Class II | Terminated |
| D-0120-2018 | 08-03-2017 | Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84 Package NDCs: 65162-687-84 | Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing. | Amneal Pharmaceuticals of New York, LLC / 136376 bottles | Class I | Terminated |
| D-1138-2017 | 08-03-2017 | Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g), Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-090-16 | Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment. | MEDLINE INDUSTRIES INC / 462 cases, 144 packets per case | Class II | Terminated |
| D-1083-2017 | 08-03-2017 | Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940 Package NDCs: 10702-026-03; 10702-026-01; 10702-026-10; 10702-027-03; 10702-027-01; 10702-027-10; 10702-028-03; 10702-028-01; 10702-028-10 | Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test. | KVK-Tech, Inc. / 35,267 bottles | Class III | Terminated |
| D-1058-2017 | 08-02-2017 | Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15 | Failed Moisture Limits: out of specification test results for water content obtained during stability testing. | Teva Pharmaceuticals USA / 2,880 cartons (30 unit dose blister pack per carton) | Class III | Terminated |
| D-1123-2017 | 08-02-2017 | Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, ?Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59 | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination | The Harvard Drug Group / 32,413 bottles | Class II | Terminated |
| D-1121-2017 | 08-02-2017 | Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09 | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination | The Harvard Drug Group / 26,891 bottles | Class II | Terminated |
| D-1122-2017 | 08-02-2017 | Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47 | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination | The Harvard Drug Group / 4,715 bottles | Class II | Terminated |
| D-1119-2017 | 08-02-2017 | Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85 | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination | The Harvard Drug Group / 7,308 bottles | Class II | Terminated |
| D-1120-2017 | 08-02-2017 | Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85 | Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination | The Harvard Drug Group / 7,272 bottles | Class II | Terminated |
| D-0126-2018 | 08-01-2017 | NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC. | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities. | The Ampt Life, LLC / 1380 packets | Class I | Terminated |
| D-1057-2017 | 07-28-2017 | Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30 | Failed Tablet/Capsule Specification: out of specification for tablet weight. | PD-Rx Pharmaceuticals, Inc. / 100 bottles | Class II | Terminated |
| D-1091-2017 | 07-26-2017 | 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09 | Presence of Particulate Matter; stainless steel | ICU Medical Inc / 436,716 flexible containers | Class II | Terminated |
| D-1082-2017 | 07-26-2017 | Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. Package NDCs: 0703-0110-01; 0703-0110-03; 0703-0113-01; 0703-0113-03; 0703-0018-01 | Presence of Particulate Matter: Silicone oil | HOSPIRA INC, LAKE FOREST / 56,340 vials | Class II | Terminated |
| D-1081-2017 | 07-26-2017 | Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50 Package NDCs: 0409-2634-10; 0409-2634-01; 0409-2634-25; 0409-2634-05; 0409-2634-50 | Presence of Particulate Matter: Silicone oil | HOSPIRA INC, LAKE FOREST / 9,009 vials | Class II | Terminated |
| D-1080-2017 | 07-26-2017 | Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01 Package NDCs: 0703-0110-01; 0703-0110-03; 0703-0113-01; 0703-0113-03; 0703-0018-01 | Presence of Particulate Matter: Silicone oil | HOSPIRA INC, LAKE FOREST / 14,300 vials | Class II | Terminated |
| D-1039-2017 | 07-25-2017 | Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53. | Failed Impurities/Degradation Specifications: high out of specification results for related compound D. | Teva Pharmaceuticals USA / 401,750 cartons | Class III | Terminated |
| D-0122-2018 | 07-24-2017 | LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health. | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs. | EZWeightLossTX LLC / 1424 bottles | Class I | Terminated |
| D-1056-2017 | 07-24-2017 | Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60 Package NDCs: 0172-5728-60; 0172-5728-70; 0172-5728-80; 0172-5729-60; 0172-5729-70 | Failed Tablet/Capsule Specification; out of specification for tablet weight | Teva Pharmaceuticals USA / 28,188 bottles | Class II | Terminated |
| D-0121-2018 | 07-24-2017 | LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health. | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs. | EZWeightLossTX LLC / 4958 bottles | Class I | Terminated |
| D-1145-2017 | 07-21-2017 | Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY | Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil | Chiavna Saffron LLC / 211 bottles; 339 boxes | Class I | Terminated |
| D-1095-2017 | 07-20-2017 | Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30 Package NDCs: 31722-833-30; 31722-833-90; 31722-833-31; 31722-833-32; 31722-834-30; 31722-834-90; 31722-834-31; 31722-834-32 | Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point. | Hetero USA Inc / 5664 bottles | Class II | Terminated |
| D-1094-2017 | 07-19-2017 | Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12 | Failed impurities/degradation specifications: Out of specification for a related compound C. | AVKARE Inc. / 1172 cartons (23440 tablets) | Class III | Terminated |
| D-1103-2017 | 07-17-2017 | Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03330, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032302. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1102-2017 | 07-17-2017 | Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03220, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032203. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1107-2017 | 07-17-2017 | Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03310, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033101. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1105-2017 | 07-17-2017 | Make Up Transparent terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03250, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032500. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1101-2017 | 07-17-2017 | Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03210, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032104. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / N/A | Class III | Terminated |
| D-1097-2017 | 07-17-2017 | Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Facial Cream, 1.66 oz. Net. Wt. 50 ml bottle, Art. 03120 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 032005. | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed. | Linde Eckstein Gmbh + Co KG / 478 balms | Class III | Terminated |
