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-0105-2024 | 10-20-2023 | Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9 | Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established. | Omega & Delta Co., Inc. / 4,848 7.5 oz bottles | Class II | Ongoing |
| D-0080-2024 | 10-20-2023 | Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01 Package NDCs: 42799-217-01; 42799-217-02 | Subpotent Drug | Edenbridge Pharmaceuticals, LLC / 4548 bottles | Class III | Terminated |
| D-0083-2024 | 10-20-2023 | Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-589-88 Package NDCs: 62756-589-83; 62756-589-01; 62756-589-88; 62756-589-08; 62756-589-18; 62756-590-83; 62756-590-01; 62756-590-88; 62756-590-08; 62756-590-18; 62756-591-83; 62756-591-01; 62756-591-88; 62756-591-08; 62756-591-18 | Failed Impurities/Degradation Specifications. | SUN PHARMACEUTICAL INDUSTRIES INC / 7392 Bottles | Class II | Terminated |
| D-0084-2024 | 10-20-2023 | Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-590-88 Package NDCs: 62756-589-83; 62756-589-01; 62756-589-88; 62756-589-08; 62756-589-18; 62756-590-83; 62756-590-01; 62756-590-88; 62756-590-08; 62756-590-18; 62756-591-83; 62756-591-01; 62756-591-88; 62756-591-08; 62756-591-18 | Failed Impurities/Degradation Specifications. | SUN PHARMACEUTICAL INDUSTRIES INC / 2304 Bottles | Class II | Terminated |
| D-0095-2024 | 10-20-2023 | Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30 Package NDCs: 68462-494-30; 68462-494-90; 68462-495-30; 68462-495-90; 68462-496-30; 68462-496-90 | Failed Dissolution Specifications | Glenmark Pharmaceuticals Inc., USA / 5,856 bottles | Class II | Ongoing |
| D-0224-2024 | 10-20-2023 | Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138 | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Botanical Be / 235 bottles | Class I | Ongoing |
| D-0226-2024 | 10-20-2023 | Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265 | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Botanical Be / 300 bottles | Class I | Ongoing |
| D-0225-2024 | 10-20-2023 | Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598 | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Botanical Be / | Class I | Ongoing |
| D-0082-2024 | 10-19-2023 | Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15 Package NDCs: 48433-230-15 | CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements. | Safecor Health, LLC / 166,022 bottles | Class II | Terminated |
| D-0097-2024 | 10-19-2023 | Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01. Package NDCs: 68382-255-06; 68382-255-14; 68382-255-16; 68382-255-01; 68382-255-05; 68382-255-30; 68382-255-77; 68382-256-14; 68382-256-01; 68382-256-16; 68382-256-05; 68382-256-30; 68382-256-77; 68382-256-06; 68382-257-14; 68382-257-01; 68382-257-16; 68382-257-05; 68382-257-30; 68382-257-77; 68382-257-06 | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. | Zydus Pharmaceuticals (USA) Inc / | Class II | Completed |
| D-0098-2024 | 10-19-2023 | Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01. Package NDCs: 68382-255-06; 68382-255-14; 68382-255-16; 68382-255-01; 68382-255-05; 68382-255-30; 68382-255-77; 68382-256-14; 68382-256-01; 68382-256-16; 68382-256-05; 68382-256-30; 68382-256-77; 68382-256-06; 68382-257-14; 68382-257-01; 68382-257-16; 68382-257-05; 68382-257-30; 68382-257-77; 68382-257-06 | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. | Zydus Pharmaceuticals (USA) Inc / | Class II | Completed |
| D-0096-2024 | 10-19-2023 | Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01 Package NDCs: 68382-255-06; 68382-255-14; 68382-255-16; 68382-255-01; 68382-255-05; 68382-255-30; 68382-255-77; 68382-256-14; 68382-256-01; 68382-256-16; 68382-256-05; 68382-256-30; 68382-256-77; 68382-256-06; 68382-257-14; 68382-257-01; 68382-257-16; 68382-257-05; 68382-257-30; 68382-257-77; 68382-257-06 | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. | Zydus Pharmaceuticals (USA) Inc / | Class II | Completed |
| D-0116-2024 | 10-18-2023 | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. Package NDCs: 51754-5001-5; 51754-5001-4; 51754-5011-4; 51754-5002-5; 51754-5012-4; 51754-5001-1; 72572-740-01; 72572-740-20 | Presence of Particulate Matter: Silicone | Exela Pharma Sciences LLC / 355,220 vials | Class I | Ongoing |
| D-0109-2024 | 10-18-2023 | Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA NDC: 77512-044-03 | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts. | Integrity Bio-Chemicals LLC / 1 55-gallon drum | Class II | Terminated |
| D-0110-2024 | 10-18-2023 | Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03 | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts. | Integrity Bio-Chemicals LLC / 1 55-gallon drum | Class II | Terminated |
| D-0111-2024 | 10-18-2023 | Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-03 | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts. | Integrity Bio-Chemicals LLC / 1-55 gallon drum | Class II | Terminated |
| D-0117-2024 | 10-18-2023 | Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-1; Carton NDC 51754-2131-4). | Presence of Particulate Matter: Silicone | Exela Pharma Sciences LLC / 23,425 vials | Class I | Ongoing |
| D-0118-2024 | 10-18-2023 | ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial: NDC 51754-1007-1; Carton: 51754-1007-3). Package NDCs: 51754-1007-1; 51754-1007-3 | Presence of Particulate Matter: Silicone | Exela Pharma Sciences LLC / 38,200 vials | Class I | Ongoing |
| D-0047-2024 | 10-18-2023 | Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16 Package NDCs: 66689-305-16 | Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus. | VistaPharm LLC / 180 bottles | Class I | Terminated |
| D-0126-2024 | 10-17-2023 | Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08 | Failed Excipient Specifications: high content of ethylene glycol (EG) | VistaPharm LLC / Prod Lot number 22ZKY1, EXP 11/27/23, 600 bottles dist; 22ZMC1 EXP12/21/23 600 bottles; 22ZTP1 EXP 03/29/24 588 bottles; 23ZAD1 EXP 07/07/24 564 bottl | Class III | Terminated |
| D-0088-2024 | 10-17-2023 | Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11 Package NDCs: 0074-4341-13; 0074-4341-90; 0074-4341-19; 0074-4341-72; 0074-4552-13; 0074-4552-90; 0074-4552-19; 0074-4552-11; 0074-4552-71; 0074-4552-72; 0074-5182-13; 0074-5182-90; 0074-5182-71; 0074-5182-19; 0074-5182-11; 0074-5182-72; 0074-6594-13; 0074-6594-90; 0074-6594-71; 0074-6594-19; 0074-6594-72; 0074-6624-13; 0074-6624-90; 0074-6624-19; 0074-6624-11; 0074-6624-71; 0074-6624-72; 0074-9296-13; 0074-9296-90; 0074-9296-19; 0074-9296-71; 0074-9296-72; 0074-7068-13; 0074-7068-90; 0074-7068-71; 0074-7068-19; 0074-7068-11; 0074-7068-72; 0074-3727-13; 0074-3727-90; 0074-3727-71; 0074-3727-19; 0074-3727-72; 0074-7069-90; 0074-7069-71; 0074-7069-19; 0074-7069-11; 0074-7069-72; 0074-7070-13; 0074-7070-90; 0074-7070-71; 0074-7070-19; 0074-7070-72; 0074-7148-90; 0074-7148-19; 0074-7148-71; 0074-7148-11; 0074-7148-72; 0074-7149-90; 0074-7149-19 | Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose. | AbbVie Inc. / 864 cartons | Class III | Ongoing |
| D-0158-2024 | 10-16-2023 | THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7 | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug. | Noah's Wholesale LLC / 173 capsules | Class I | Ongoing |
| D-0086-2024 | 10-13-2023 | Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10. Package NDCs: 55111-725-30; 55111-725-90; 55111-725-01; 55111-725-10; 55111-725-79; 55111-725-78; 55111-593-30; 55111-593-90; 55111-593-05; 55111-593-79; 55111-593-78; 55111-594-30; 55111-594-90; 55111-594-05; 55111-594-79; 55111-594-78 | Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg. | Dr. Reddy's Laboratories, Inc. / 1,656 bottles | Class II | Terminated |
| D-0045-2024 | 10-05-2023 | Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores. | CGMP Deviations: OTC products were stored outside of labeled temperature requirements. | Dollar Tree Distribution, Inc. / 4,261,383 units of various products | Class II | Ongoing |
| D-0072-2024 | 10-04-2023 | VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68. | Labeling: Not Elsewhere Classified | Denver Solutions, LLC DBA Leiters Health / 25,908 IV bags | Class III | Terminated |
| D-0070-2024 | 10-04-2023 | Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70 | Labeling: Not Elsewhere Classified | Denver Solutions, LLC DBA Leiters Health / 6,276 IV bags | Class III | Terminated |
| D-0071-2024 | 10-04-2023 | VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68. | Labeling: Not Elsewhere Classified | Denver Solutions, LLC DBA Leiters Health / 33,480 IV Bags | Class III | Terminated |
| D-0044-2024 | 10-04-2023 | Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-737-86 Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13 | Failed Dissolution Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / 144 bottles | Class III | Terminated |
| D-0091-2024 | 10-04-2023 | Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79 Package NDCs: 53329-169-79 | CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate. | MEDLINE INDUSTRIES, LP - Northfield / | Class II | Terminated |
| D-0040-2024 | 10-03-2023 | Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979 | Subpotent: Failing Test Results for Epinephrine | Imprimis NJOF, LLC / 364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag) | Class III | Terminated |
| D-0101-2024 | 10-02-2023 | 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4904-11 Package NDCs: 0409-4903-11; 0409-4903-34; 0409-4904-11; 0409-4904-34; 0409-1323-15; 0409-1323-05; 0409-9137-11; 0409-9137-05 | Presence of Particulate Matter: identified as glass. | Pfizer Inc. / 21,390 vials | Class I | Terminated |
| D-0102-2024 | 10-02-2023 | 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11 Package NDCs: 0409-4903-11; 0409-4903-34; 0409-4904-11; 0409-4904-34; 0409-1323-15; 0409-1323-05; 0409-9137-11; 0409-9137-05 | Presence of Particulate Matter: identified as glass. | Pfizer Inc. / 3,200 vials | Class I | Terminated |
| D-0100-2024 | 10-02-2023 | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24 | Presence of Particulate Matter: identified as glass. | Pfizer Inc. / 24,900 vials | Class I | Terminated |
| D-0054-2024 | 10-02-2023 | Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 881 pre-filled syringes | Class II | Terminated |
| D-0050-2024 | 10-02-2023 | Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 2862 Syringes | Class II | Terminated |
| D-0056-2024 | 10-02-2023 | Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 2484 syringes | Class II | Terminated |
| D-0052-2024 | 10-02-2023 | Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 201 kits | Class II | Terminated |
| D-0062-2024 | 10-02-2023 | Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 1598 droppers | Class II | Terminated |
| D-0063-2024 | 10-02-2023 | Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 662 dropper | Class II | Terminated |
| D-0059-2024 | 10-02-2023 | Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 9673 vials | Class II | Terminated |
| D-0060-2024 | 10-02-2023 | TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 1693 droppers | Class II | Terminated |
| D-0055-2024 | 10-02-2023 | Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 2181 droppers | Class II | Terminated |
| D-0053-2024 | 10-02-2023 | Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 128 bags | Class II | Terminated |
| D-0064-2024 | 10-02-2023 | Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 860 syringes | Class II | Terminated |
| D-0058-2024 | 10-02-2023 | Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 2176 syringes | Class II | Terminated |
| D-0051-2024 | 10-02-2023 | Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 26 vials | Class II | Terminated |
| D-0065-2024 | 10-02-2023 | Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 136 syringes | Class II | Terminated |
| D-0061-2024 | 10-02-2023 | Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 130 | Class II | Terminated |
| D-0057-2024 | 10-02-2023 | Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 4972 syringes | Class II | Terminated |
| D-0067-2024 | 09-29-2023 | ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA | Microbial contamination of Non-Sterile Products | Biomic Sciences, LLC dba ION Intelligence of Nature / N/A | Class I | Terminated |
| D-0068-2024 | 09-29-2023 | ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA | Microbial contamination of Non-Sterile Products | Biomic Sciences, LLC dba ION Intelligence of Nature / N/A | Class II | Terminated |
| D-0069-2024 | 09-29-2023 | Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA | Microbial contamination of Non-Sterile Products | Biomic Sciences, LLC dba ION Intelligence of Nature / N/A | Class II | Terminated |
| D-0041-2024 | 09-28-2023 | Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular, epidural, or intrathecal use, Mfd. in India for Auromedics Pharma LLC., E Windsor, NJ, 08520, NDC 55150-385-01. Package NDCs: 55150-384-01; 55150-385-01 | Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial. | Eugia US LLC / 1,626 vials | Class II | Ongoing |
| D-0081-2024 | 09-28-2023 | Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01 Package NDCs: 45802-396-01; 45802-396-02 | Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process. | Padagis US LLC / 10,512 cartons | Class II | Ongoing |
| D-0042-2024 | 09-25-2023 | BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04 | Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound). | Scynexis, Inc. / 17,376 | Class I | Completed |
| D-0066-2024 | 09-22-2023 | Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25 Package NDCs: 0054-4550-25; 0054-4550-15; 0054-8550-25 | Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring. | West-Ward Columbus Inc / 2,673 cartons | Class III | Ongoing |
| D-0017-2024 | 09-21-2023 | fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 190 250 mL bags | Class II | Terminated |
| D-0005-2024 | 09-21-2023 | PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 3,384 10 mL syringes | Class II | Terminated |
| D-0010-2024 | 09-21-2023 | fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 598 10 mL syringes | Class II | Terminated |
| D-0002-2024 | 09-21-2023 | ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 4,775 5 mL Syringes | Class II | Terminated |
| D-0011-2024 | 09-21-2023 | fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 688 50 mL syringes | Class II | Terminated |
| D-0003-2024 | 09-21-2023 | ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 1,590 5 mL Syringes. | Class II | Terminated |
| D-0021-2024 | 09-21-2023 | fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 476, 50 mL Syringes | Class II | Terminated |
| D-0031-2024 | 09-21-2023 | HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 2,664 30 mL syringes | Class II | Terminated |
| D-0014-2024 | 09-21-2023 | fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 403 bags | Class II | Terminated |
| D-0026-2024 | 09-21-2023 | succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 3,590 10 mL syringes | Class II | Terminated |
| D-0032-2024 | 09-21-2023 | HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 398 5 mL syringes | Class II | Terminated |
| D-0004-2024 | 09-21-2023 | lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 1,992 5 mL syringes | Class II | Terminated |
| D-0030-2024 | 09-21-2023 | HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 274 30 mL syringes | Class II | Terminated |
| D-0012-2024 | 09-21-2023 | fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 5,378 100 mL bags | Class II | Terminated |
| D-0019-2024 | 09-21-2023 | fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 50, 3 mL syringes | Class II | Terminated |
| D-0023-2024 | 09-21-2023 | fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 71 100 mL bags | Class II | Terminated |
| D-0001-2024 | 09-21-2023 | fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 1,762 Syringes | Class II | Terminated |
| D-0024-2024 | 09-21-2023 | fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2001-2 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 962 30 mL syringes. | Class II | Terminated |
| D-0016-2024 | 09-21-2023 | fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 60 250 mL bags | Class II | Terminated |
| D-0028-2024 | 09-21-2023 | HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 1,190 50 mL syringes | Class II | Terminated |
| D-0007-2024 | 09-21-2023 | PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 19,510 10 mL syringes. | Class II | Terminated |
| D-0025-2024 | 09-21-2023 | fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 1,459 30 mL syringes | Class II | Terminated |
| D-0009-2024 | 09-21-2023 | fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 1,767 3 mL syringes | Class II | Terminated |
| D-0029-2024 | 09-21-2023 | HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 4,550 30 mL syringes | Class II | Terminated |
| D-0020-2024 | 09-21-2023 | fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 174, 5 mL syringes. | Class II | Terminated |
| D-0027-2024 | 09-21-2023 | HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 1,190 30 mL syringes | Class II | Terminated |
| D-0018-2024 | 09-21-2023 | midazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 419 50 mL syringes | Class II | Terminated |
| D-0013-2024 | 09-21-2023 | fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 1,792 bags | Class II | Terminated |
| D-0006-2024 | 09-21-2023 | PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 3,081 syringes | Class II | Terminated |
| D-0015-2024 | 09-21-2023 | fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 895 50 mL syringes | Class II | Terminated |
| D-0022-2024 | 09-21-2023 | fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 240 100 mL bags | Class II | Terminated |
| D-0008-2024 | 09-21-2023 | rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 1,389 5 mL syringes | Class II | Terminated |
| D-0038-2024 | 09-21-2023 | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 Package NDCs: 68382-255-06; 68382-255-14; 68382-255-16; 68382-255-01; 68382-255-05; 68382-255-30; 68382-255-77; 68382-256-14; 68382-256-01; 68382-256-16; 68382-256-05; 68382-256-30; 68382-256-77; 68382-256-06; 68382-257-14; 68382-257-01; 68382-257-16; 68382-257-05; 68382-257-30; 68382-257-77; 68382-257-06 | Failed Dissolution Specifications | Zydus Pharmaceuticals (USA) Inc / 7,248 bottles | Class II | Terminated |
| D-0049-2024 | 09-20-2023 | Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01. Package NDCs: 10702-013-01; 10702-014-01 | Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles. | KVK-Tech, Inc. / 1488 bottles | Class I | Terminated |
| D-0043-2024 | 09-20-2023 | MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05 | Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim. | Imprimis NJOF, LLC / 6,228 bags + 15,360 boxes | Class III | Terminated |
| D-1178-2023 | 09-12-2023 | Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526. Package NDCs: 62935-753-75; 62935-754-74; 62935-755-75; 62935-223-05; 62935-221-04; 62935-224-05; 62935-303-30; 62935-305-29; 62935-304-30; 62935-453-45; 62935-454-44; 62935-455-45 | Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product. | Tolmar, Inc. / 2990 cartons | Class III | Terminated |
| D-1174-2023 | 09-08-2023 | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22. | Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals. | Novartis Pharmaceuticals Corp. / 1272 bottles | Class I | Ongoing |
| D-0046-2024 | 09-08-2023 | TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, NJ 08628 | Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis | Church & Dwight Inc / 5,316 bottles | Class I | Ongoing |
| D-1172-2023 | 09-07-2023 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96 Package NDCs: 47335-506-96; 47335-507-97 | Subpotent: Out of Specification result observed for low assay | SUN PHARMACEUTICAL INDUSTRIES INC / 69,707 cartons | Class III | Terminated |
| D-1173-2023 | 09-05-2023 | Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle, DISTRIBUTED BY THEKROGER CO. CINCINNATI, OHIO 45202, UPC 011110380807 | Incorrect/Undeclared Excipients. | Vi-Jon, LLC / 245,904 Bottles | Class III | Terminated |
| D-1148-2023 | 09-05-2023 | Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511. Package NDCs: 71839-122-25; 71839-122-10; 71839-122-01 | Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials. | BE PHARMACEUTICALS AG / 41,148 vials | Class II | Terminated |
| D-0039-2024 | 09-01-2023 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11 | Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point. | Amerisource Health Services LLC / 3,344 cartons | Class III | Terminated |
| D-1167-2023 | 09-01-2023 | octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 30,490 units | Class II | Ongoing |
| D-1157-2023 | 09-01-2023 | TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-417-19. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,000 units | Class II | Ongoing |
