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-0440-2018 | 12-27-2017 | Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0466-2018 | 12-27-2017 | Methadone HCl Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0460-2018 | 12-27-2017 | Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0415-2018 | 12-22-2017 | Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30 Package NDCs: 31722-706-30; 31722-706-60; 31722-706-01; 31722-706-05; 31722-706-10; 31722-707-30; 31722-707-60; 31722-707-01; 31722-707-05; 31722-707-10; 31722-708-30; 31722-708-60; 31722-708-01; 31722-708-05; 31722-708-10 | Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution. | Hetero Labs Limited Unit V / 8,436 bottles | Class II | Terminated |
| D-0223-2018 | 12-22-2017 | Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10 Package NDCs: 31722-510-30; 31722-510-01; 31722-510-10; 31722-510-90; 31722-511-30; 31722-511-01; 31722-511-10; 31722-511-90; 31722-512-30; 31722-512-01; 31722-512-10; 31722-512-90; 31722-513-30; 31722-513-01; 31722-513-10; 31722-513-90; 31722-514-30; 31722-514-01; 31722-514-05; 31722-514-90 | Presence of foreign substance: metallic razor blade was found in one bottle. | Hetero Labs, Ltd. - Unit III / N/A | Class III | Terminated |
| D-0249-2018 | 12-21-2017 | Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3 Package NDCs: 51672-1294-1; 51672-1294-2; 51672-1294-3; 51672-1258-1; 51672-1258-2; 51672-1258-6; 51672-1258-3; 51672-1259-1; 51672-1259-2; 51672-1259-6; 51672-1259-3; 3516721258 | Failed Content Uniformity Specifications | Taro Pharmaceuticals U.S.A., Inc. / 27,792 tubes | Class III | Terminated |
| D-0337-2018 | 12-20-2017 | Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51 Package NDCs: 55150-242-51 | Presence of Particulate Matter; white particulate matter identified as mold was found in one bag | AuroMedics Pharma LLC / 9,050 bags | Class I | Terminated |
| D-0604-2018 | 12-20-2017 | DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451. Package NDCs: 49230-206-30; 49230-206-32; 49230-206-50; 49230-206-52; 49230-206-62; 49230-209-30; 49230-209-32; 49230-209-50; 49230-209-52; 49230-209-62; 49230-212-30; 49230-212-32; 49230-212-50; 49230-212-52; 49230-212-62; 49230-209-23 | Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag. | Fresenius Medical Care Renal Therapies Group, LLC / 3,734 cases | Class II | Terminated |
| D-0231-2018 | 12-20-2017 | Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics Montreal, Quebec H9R 2Y6 Made in Fabrique au Canada. UPC code 6 26354 10955 0 | Failed Stability Specifications:stability failure at 12 months, long term RT conditions. | Odan Laboratories Ltd / 21 jars | Class II | Terminated |
| D-0232-2018 | 12-20-2017 | Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml / 2 oz), Night Cream (15 g / 0.5 oz), Day Cream SPF15 {Octinoxate 7%, Avobenzone 2% and Oxybenzone 5%} (15 g / 0.5 oz), Eye Cream (6 g / 0.21 oz).Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics (USA) Inc. 99 Hudson, New York, NY, USA. UPC code 6 06354 61322 4 | Failed Stability Specifications:stability failure at 12 months, long term RT conditions. | Odan Laboratories Ltd / 179 kits | Class II | Terminated |
| D-0228-2018 | 12-19-2017 | Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01 Package NDCs: 29300-138-01; 29300-138-05; 29300-138-10; 29300-139-01; 29300-139-05; 29300-139-10; 29300-140-01; 29300-140-05; 29300-140-10 | Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium. | Unichem Pharmaceuticals Usa Inc / 96,876 Bottles of 30s | Class II | Terminated |
| D-0111-2018 | 12-18-2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10 Package NDCs: 13811-709-10; 13811-706-10; 13811-707-10; 13811-708-10; 13811-710-10; 13811-710-30 | Subpotent Drug | Osmotica Pharmaceutical Corp / 9919 bottles | Class III | Terminated |
| D-0110-2018 | 12-18-2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10 Package NDCs: 13811-709-10; 13811-706-10; 13811-707-10; 13811-708-10; 13811-710-10; 13811-710-30 | Subpotent Drug | Osmotica Pharmaceutical Corp / 10064 bottles | Class III | Terminated |
| D-0610-2018 | 12-15-2017 | Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1 | Presence of particulate matter | Amneal Pharmaceuticals / 12,584 vials | Class II | Terminated |
| D-0211-2018 | 12-15-2017 | Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47 | CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer. | Akorn Inc / 4,885 bottles | Class III | Terminated |
| D-0112-2018 | 12-15-2017 | 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10 Package NDCs: 0264-2304-00; 0264-2304-10 | Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap | B. Braun Medical Inc / 2,576 containers | Class II | Terminated |
| D-0217-2018 | 12-14-2017 | Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022 | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | SHISEIDO AMERICA INC. / N/A | Class II | Terminated |
| D-0214-2018 | 12-14-2017 | bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01 | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | SHISEIDO AMERICA INC. / 248,661 bottle and /tubes | Class II | Terminated |
| D-0218-2018 | 12-14-2017 | Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022, NDC 58411-256-60 | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | SHISEIDO AMERICA INC. / N/A | Class II | Terminated |
| D-0215-2018 | 12-14-2017 | Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60 | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | SHISEIDO AMERICA INC. / N/A | Class II | Terminated |
| D-0216-2018 | 12-14-2017 | Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022, | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | SHISEIDO AMERICA INC. / N/A | Class II | Terminated |
| D-0208-2018 | 12-14-2017 | Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01. | Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing. | Teva Pharmaceuticals USA / 4,969 bottles | Class II | Terminated |
| D-0242-2018 | 12-14-2017 | SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47 Package NDCs: 0597-0075-41; 0597-0075-75; 0597-0075-47 | Failed Stability Specifications | Boehringer Ingelheim Pharmaceuticals, Inc. / 45,008 units/90 capsules each unit | Class II | Terminated |
| D-0545-2018 | 12-13-2017 | INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013. | Failed Stability Specifications: Product stability testing results did not meet specifications for iron content. | ALLERGAN / 163,694 cartons | Class II | Terminated |
| D-0133-2018 | 12-12-2017 | Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01 Package NDCs: 59922-631-01 | Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle. | Keryx Biopharmaceuticals, Inc. / 2,488 200-bottles | Class III | Terminated |
| D-0210-2018 | 12-12-2017 | Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX 76006, NDC 58657-500-16 Package NDCs: 58657-500-04; 58657-500-16 | Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia | Woodfield Pharmaceutical, LLC / 15,707 bottles | Class II | Terminated |
| D-0471-2018 | 12-07-2017 | BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481 | Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine. | BotanicalNow / 5 bottles | Class I | Terminated |
| D-0156-2018 | 12-07-2017 | Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12 | Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date. | SCA Pharmaceuticals / 1248 syringes | Class II | Terminated |
| D-0245-2018 | 12-07-2017 | Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case Code: 00070501302866 | Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area. | Johnson & Johnson / | Class II | Terminated |
| D-0243-2018 | 12-07-2017 | Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product in a can, NET WT. 5 OZ (141 g) , Distributed by Johnson & Johnson Consumer Inc. Skillman, NJ 08558, UPC 0 70501 11131 4 | Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area. | Johnson & Johnson / 67,260 units | Class II | Terminated |
| D-0244-2018 | 12-07-2017 | Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%), aerosolized product in a can, NET WT. 5 OZ. (141 g) Distributed By: Johnson & Johnson Consumer Inc. Skillman, NJ 08558. UPC: 0 70501 10053 0 | Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area. | Johnson & Johnson / | Class II | Terminated |
| D-0153-2018 | 12-05-2017 | Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10 | Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL | Sanofi-Aventis U.S. LLC / 11,474 cartons of 10 syringes per carton | Class III | Terminated |
| D-0340-2018 | 12-04-2017 | Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00 Package NDCs: 55150-202-00; 55150-202-10; 55150-202-25 | Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass | AuroMedics Pharma LLC / 66,100 vials | Class I | Terminated |
| D-0155-2018 | 12-04-2017 | Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50 | Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg | Solco Healtcare US LLC / N/A | Class II | Terminated |
| D-0154-2018 | 12-04-2017 | Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10 | Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile. | ALLERGAN / 12,699 bottles | Class II | Terminated |
| D-0323-2018 | 11-30-2017 | All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583. | Lack of sterility assurance. | Intrathecal Compounding Specialist, LLC / Unknown | Class II | Terminated |
| D-0320-2018 | 11-30-2017 | All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583. | Lack of sterility assurance. | Intrathecal Compounding Specialist, LLC / Unknown. | Class II | Terminated |
| D-0321-2018 | 11-30-2017 | All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583. | Lack of sterility assurance. | Intrathecal Compounding Specialist, LLC / Unknown | Class II | Terminated |
| D-0414-2018 | 11-30-2017 | Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc., Palmetto, FL | Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil | BYL Solutions Inc. / 329 tins | Class III | Terminated |
| D-0322-2018 | 11-30-2017 | All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583. | Lack of sterility assurance. | Intrathecal Compounding Specialist, LLC / Unknown | Class II | Terminated |
| D-0247-2018 | 11-29-2017 | BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5 | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall. | Blue Fusion Natural / 300 pill cards | Class I | Terminated |
| D-0209-2018 | 11-29-2017 | Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09. Package NDCs: 43547-367-03; 43547-367-09; 43547-367-50; 43547-367-11; 43547-368-03; 43547-368-09; 43547-368-50; 43547-368-11; 43547-369-03; 43547-369-09; 43547-369-50; 43547-369-11; 43547-370-03; 43547-370-09; 43547-370-50; 43547-370-11 | Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle. | Prinston Pharmaceutical Inc / 21,987 bottles | Class II | Terminated |
| D-0108-2018 | 11-28-2017 | Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73. Package NDCs: 0093-1172-01; 0093-1172-10; 0093-1174-01; 0093-1174-10; 0093-4125-73; 0093-4125-74; 0093-4127-73; 0093-4127-74 | Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities. | Teva Pharmaceuticals USA / 42,384 bottles | Class III | Terminated |
| D-0100-2018 | 11-28-2017 | Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0. | CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity. | EAI-JR286 INC / 5,355 tubes | Class II | Terminated |
| D-0097-2018 | 11-21-2017 | Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068 Package NDCs: 68180-294-07; 68180-294-03; 68180-294-09; 68180-294-06; 68180-295-06; 68180-295-09; 68180-295-03; 68180-296-03; 68180-296-06; 68180-296-09; 68180-297-06; 68180-297-09; 68180-297-03; 3681802950 | Failed Dissolution Specification | Lupin Pharmaceuticals Inc. / 111,648 units | Class III | Terminated |
| D-0101-2018 | 11-20-2017 | Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534 Package NDCs: 68382-097-16; 68382-097-01; 68382-097-05; 68382-097-10; 68382-097-06; 68382-098-06; 68382-098-16; 68382-098-01; 68382-098-05; 68382-098-10; 68382-099-06; 68382-099-16; 68382-099-01; 68382-099-05; 68382-099-10; 68382-001-06; 68382-001-16; 68382-001-01; 68382-001-05; 68382-001-10 | Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets | Zydus Pharmaceuticals USA Inc / 19812 bottles | Class II | Terminated |
| D-0336-2018 | 11-20-2017 | Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559 | CGMP Deviations: Market complaints related to "gritty texture". | Glenmark Pharmaceuticals Inc., USA / 5136 tubes | Class II | Terminated |
| D-0125-2018 | 11-20-2017 | Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28 | Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active. | Teva Pharmaceuticals USA / 5,374 blister cards/28 tablets | Class II | Terminated |
| D-0470-2018 | 11-19-2017 | Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA | Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil. | www.blankterrmall.com / 10 boxes | Class I | Terminated |
| D-0092-2018 | 11-17-2017 | Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09 Package NDCs: 68180-485-03; 68180-485-09; 68180-485-02; 68180-486-09; 68180-486-02; 68180-486-03; 68180-487-09; 68180-487-02; 68180-487-03; 68180-488-09; 68180-488-02; 68180-488-03 | Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle. | Lupin Limited / N/A | Class II | Terminated |
| D-0170-2018 | 11-16-2017 | Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 20 jars | Class II | Terminated |
| D-0189-2018 | 11-16-2017 | QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 126 vials | Class II | Terminated |
| D-0185-2018 | 11-16-2017 | Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 2,535 vials | Class II | Terminated |
| D-0203-2018 | 11-16-2017 | Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 479 vials | Class II | Terminated |
| D-0174-2018 | 11-16-2017 | Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 1,203 vials | Class II | Terminated |
| D-0192-2018 | 11-16-2017 | Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 30 droptainers | Class II | Terminated |
| D-0206-2018 | 11-16-2017 | 7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 90 capsules | Class II | Terminated |
| D-0167-2018 | 11-16-2017 | Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 3,280 jars | Class II | Terminated |
| D-0204-2018 | 11-16-2017 | Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 3612 vials | Class II | Terminated |
| D-0187-2018 | 11-16-2017 | PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 3,000 tablets | Class II | Terminated |
| D-0175-2018 | 11-16-2017 | Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 6,414 vials | Class II | Terminated |
| D-0193-2018 | 11-16-2017 | Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 3,000 tablets | Class II | Terminated |
| D-0200-2018 | 11-16-2017 | T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 173 vials | Class II | Terminated |
| D-0169-2018 | 11-16-2017 | Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 90 capsules | Class II | Terminated |
| D-0168-2018 | 11-16-2017 | Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 300 jars | Class II | Terminated |
| D-0182-2018 | 11-16-2017 | Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 40 jars | Class II | Terminated |
| D-0205-2018 | 11-16-2017 | Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 5786 vials | Class II | Terminated |
| D-0196-2018 | 11-16-2017 | Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 157 vials | Class II | Terminated |
| D-0176-2018 | 11-16-2017 | Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 2,239 vials | Class II | Terminated |
| D-0184-2018 | 11-16-2017 | Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 696 vials | Class II | Terminated |
| D-0164-2018 | 11-16-2017 | Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 490 jars | Class II | Terminated |
| D-0161-2018 | 11-16-2017 | Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 15,700 capsules | Class II | Terminated |
| D-0173-2018 | 11-16-2017 | Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 2,239 tablets | Class II | Terminated |
| D-0166-2018 | 11-16-2017 | Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 1,380 jars | Class II | Terminated |
| D-0195-2018 | 11-16-2017 | Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 597 vials | Class II | Terminated |
| D-0179-2018 | 11-16-2017 | Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 30 jars | Class II | Terminated |
| D-0183-2018 | 11-16-2017 | Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 970 capsules | Class II | Terminated |
| D-0190-2018 | 11-16-2017 | QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 122 vials | Class II | Terminated |
| D-0180-2018 | 11-16-2017 | Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 1,009 vials | Class II | Terminated |
| D-0202-2018 | 11-16-2017 | Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 81 droptainers | Class II | Terminated |
| D-0199-2018 | 11-16-2017 | Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 94 vials | Class II | Terminated |
| D-0186-2018 | 11-16-2017 | Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 963 bags | Class II | Terminated |
| D-0162-2018 | 11-16-2017 | Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 80 vials | Class II | Terminated |
| D-0188-2018 | 11-16-2017 | Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 300 jars | Class II | Terminated |
| D-0191-2018 | 11-16-2017 | QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 129 vials | Class II | Terminated |
| D-0171-2018 | 11-16-2017 | Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 100 jars | Class II | Terminated |
| D-0197-2018 | 11-16-2017 | Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 898 vials | Class II | Terminated |
| D-0177-2018 | 11-16-2017 | Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 7,862 vials | Class II | Terminated |
| D-0163-2018 | 11-16-2017 | Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 22,520 capsules | Class II | Terminated |
| D-0181-2018 | 11-16-2017 | Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 596 vials | Class II | Terminated |
| D-0194-2018 | 11-16-2017 | Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 80 cartridges | Class II | Terminated |
| D-0207-2018 | 11-16-2017 | 7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 90 capsules | Class II | Terminated |
| D-0172-2018 | 11-16-2017 | Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 300 jars | Class II | Terminated |
| D-0165-2018 | 11-16-2017 | Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 4,530 jars | Class II | Terminated |
| D-0201-2018 | 11-16-2017 | Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 297 droptainers | Class II | Terminated |
| D-0198-2018 | 11-16-2017 | Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2 mg/mL), For Intracavernous Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 235 vials | Class II | Terminated |
| D-0178-2018 | 11-16-2017 | Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. | KRS Global Biotechnology, Inc / 2,274 vials | Class II | Terminated |
| D-0827-2018 | 11-13-2017 | 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10. | Lack of Assurance of Sterility | Fresenius Medical Care Renal Therapies Group, LLC / 25,356 1 liter bags | Class II | Terminated |
| D-0107-2018 | 11-13-2017 | Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013 | Failed Impurities/Degradation Specifications | Elite Laboratories Inc. / 1264 bottles | Class III | Terminated |
| D-0124-2018 | 11-11-2017 | Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India | Superpotent | Renaissance Lakewood, LLC / 24,569 bags | Class III | Terminated |
