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-0019-2018 | 10-10-2017 | Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001. | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 1658 syringes | Class II | Terminated |
| D-0017-2018 | 10-10-2017 | fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025011001 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 9030 cassetts | Class II | Terminated |
| D-0021-2018 | 10-10-2017 | Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025016201 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 966 cassettes | Class II | Terminated |
| D-0025-2018 | 10-10-2017 | Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025088801 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 2792 syringes | Class II | Terminated |
| D-0018-2018 | 10-10-2017 | fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011001 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / N/A | Class II | Terminated |
| D-0027-2018 | 10-10-2017 | VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025007001 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 2443 bags | Class II | Terminated |
| D-0016-2018 | 10-10-2017 | ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025024801 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 972 syringes | Class II | Terminated |
| D-0024-2018 | 10-10-2017 | Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 2173 cassettes | Class II | Terminated |
| D-0015-2018 | 10-10-2017 | Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 1359 bags | Class II | Terminated |
| D-0026-2018 | 10-10-2017 | VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025002501 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 3136 bags | Class II | Terminated |
| D-0022-2018 | 10-10-2017 | Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011501 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 3550 bags | Class II | Terminated |
| D-0020-2018 | 10-10-2017 | Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025003201 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 7578 bags | Class II | Terminated |
| D-0028-2018 | 10-10-2017 | Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025014801 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 481 bags | Class II | Terminated |
| D-0023-2018 | 10-10-2017 | OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025000101 | Lack of Assurance of Sterility. | Banner Pharmacy Services, LLC / 24306 units | Class II | Terminated |
| D-0055-2018 | 10-06-2017 | Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15. | Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid. | AVKARE Inc. / 274 cartons | Class II | Terminated |
| D-0058-2018 | 10-06-2017 | A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, [email protected] Bar-Code A105212014 | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall. | Kiriko, LLC. / 700 bottles | Class II | Terminated |
| D-0095-2018 | 10-06-2017 | No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by NEW RELIANCE TRADING, INC., 5563 59th St., Maspeth, New York, 11378-2358, UPC 8993138993349, 5842109854239. | Marketed Without an Approved NDA/ANDA | NEW RELIANCE TRADING, INC. / 513 foil packets | Class II | Terminated |
| D-0070-2018 | 10-05-2017 | Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01 Package NDCs: 67618-153-01; 67618-153-03 | Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum. | Purdue Pharma, LP / 3997 swabsticks | Class II | Terminated |
| D-0009-2018 | 10-03-2017 | Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, Made in India Package NDCs: 55111-118-30; 55111-118-40; 55111-118-60; 55111-118-90; 55111-118-04; 55111-118-18; 55111-118-24; 55111-118-35; 55111-118-81; 55111-118-79; 55111-118-12; 55111-396-35; 55111-396-50; 55111-396-65; 55111-396-90; 55111-396-44; 55111-396-01; 55111-396-13; 55111-396-32; 55111-396-08; 55111-396-16; 49035-118-30 | Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval. | Dr. Reddy's Laboratories, Inc. / 569376 bottles | Class III | Terminated |
| D-0010-2018 | 10-02-2017 | Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbrouck Heights, NJ 07604, NDC 29300-126-13. Package NDCs: 29300-126-13; 29300-126-01; 29300-126-05; 29300-127-13; 29300-127-01; 29300-127-05 | Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing. | Unichem Pharmaceuticals Usa Inc / 96,876 bottles | Class II | Terminated |
| D-0085-2018 | 09-28-2017 | Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05 Package NDCs: 69315-904-01; 69315-904-05; 69315-904-10; 69315-905-01; 69315-905-05; 69315-905-10; 69315-906-01; 69315-906-05; 69315-906-10 | Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam | Leading Pharma, LLC / 2952 500-count bottles | Class II | Terminated |
| D-0008-2018 | 09-27-2017 | Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417 | CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed | United Pharmacy / 268 vials | Class II | Terminated |
| D-0212-2018 | 09-27-2017 | FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR KR, FOR MANUFACTURING, PROCESSING OR REPACKAGING | Microbial Contamination of Non-Sterile Products | Pfizer Manufacturing Deutschland GmbH / a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets | Class II | Terminated |
| D-0221-2018 | 09-26-2017 | Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20 | Superpotent Drug | Pharmedium Services, LLC / 2390 syringes | Class II | Terminated |
| D-0132-2018 | 09-26-2017 | HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78 | Labeling: Incorrect or Missing Lot and/or Exp. Date | Pharmedium Services, LLC / Unknown | Class III | Terminated |
| D-0131-2018 | 09-26-2017 | morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78 | Labeling: Incorrect or Missing Lot and/or Exp. Date | Pharmedium Services, LLC / Unknown | Class III | Terminated |
| D-0130-2018 | 09-26-2017 | morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28 | Labeling: Incorrect or Missing Lot and/or Exp. Date | Pharmedium Services, LLC / Unknown | Class III | Terminated |
| D-0013-2018 | 09-26-2017 | Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61. | Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity. | The Harvard Drug Group / 3,935 cartons | Class II | Terminated |
| D-0057-2018 | 09-25-2017 | Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080. | Subpotent Drug: low out of specification results. | Precision Dose Inc. / 801 cases | Class III | Terminated |
| D-0012-2018 | 09-25-2017 | methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10 | Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product. | RXQ Compounding LLC / 945 vials | Class II | Terminated |
| D-1438-2019 | 09-25-2017 | Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01 | Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets. | Amneal Pharmaceuticals, Inc. / 19104 units | Class III | Terminated |
| D-1439-2019 | 09-25-2017 | Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01 | Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets. | Amneal Pharmaceuticals, Inc. / 19176 units | Class III | Terminated |
| D-1179-2017 | 09-25-2017 | Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540. Package NDCs: 0781-3400-78; 0781-3400-95; 0781-3402-78; 0781-3402-95; 0781-3407-78; 0781-3407-95; 0781-3404-85; 0781-3404-95; 0781-3408-80; 0781-3408-95 | Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels. | Sandoz Inc / 13,435 shrink wrap packs | Class III | Terminated |
| D-0007-2018 | 09-22-2017 | Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01 | Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert. | Boehringer Ingelheim Pharmaceuticals, Inc. / 128 bottles | Class III | Terminated |
| D-0254-2018 | 09-21-2017 | Medline Vaginal Delivery CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 2 cases | Class II | Terminated |
| D-0271-2018 | 09-21-2017 | Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 700 cases | Class II | Terminated |
| D-0264-2018 | 09-21-2017 | Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 65,563 cases | Class II | Terminated |
| D-0294-2018 | 09-21-2017 | Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 1,250 cases | Class II | Terminated |
| D-0287-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 3,089 cases | Class II | Terminated |
| D-0298-2018 | 09-21-2017 | Medline IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 350 cases | Class II | Terminated |
| D-0311-2018 | 09-21-2017 | Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 450 cases | Class II | Terminated |
| D-0252-2018 | 09-21-2017 | Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 11,750 cases | Class II | Terminated |
| D-0315-2018 | 09-21-2017 | Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / | Class II | Terminated |
| D-0258-2018 | 09-21-2017 | Medline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 21 cases | Class II | Terminated |
| D-0266-2018 | 09-21-2017 | Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 14,675 cases | Class II | Terminated |
| D-0303-2018 | 09-21-2017 | Medline Pacemaker Implant Pack, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 66 cases | Class II | Terminated |
| D-0299-2018 | 09-21-2017 | Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates., Tahlequah, OK 74464 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 5,400 cases | Class II | Terminated |
| D-0314-2018 | 09-21-2017 | Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 592 ases | Class II | Terminated |
| D-0270-2018 | 09-21-2017 | Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 80 cases | Class II | Terminated |
| D-0292-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 100 cases | Class II | Terminated |
| D-0274-2018 | 09-21-2017 | Medline INCISION AND DRAINAGE TRAY Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 60 cases | Class II | Terminated |
| D-0304-2018 | 09-21-2017 | Medline Hip Replacement, Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 88 cases | Class II | Terminated |
| D-0297-2018 | 09-21-2017 | Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 2,336 cases | Class II | Terminated |
| D-0318-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 34,495 cases | Class II | Terminated |
| D-0309-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 98,901 cases | Class II | Terminated |
| D-0281-2018 | 09-21-2017 | Medline GHS Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 1100 cases | Class II | Terminated |
| D-0305-2018 | 09-21-2017 | Medline Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 149 cases | Class II | Terminated |
| D-0283-2018 | 09-21-2017 | Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 80 cases | Class II | Terminated |
| D-0280-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 700 cases | Class II | Terminated |
| D-0261-2018 | 09-21-2017 | Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 375 cases | Class II | Terminated |
| D-0312-2018 | 09-21-2017 | Medline Suture Removal Pack Latex Safe, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 663 cases | Class II | Terminated |
| D-0278-2018 | 09-21-2017 | Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 56 cases | Class II | Terminated |
| D-0302-2018 | 09-21-2017 | Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 2,369 cases | Class II | Terminated |
| D-0276-2018 | 09-21-2017 | Medline Catheter Insertion Kit, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 4,100 cases | Class II | Terminated |
| D-0289-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 700 cases | Class II | Terminated |
| D-0265-2018 | 09-21-2017 | Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 10,375 cases | Class II | Terminated |
| D-0300-2018 | 09-21-2017 | Medline Debridement Tray, Sterile, Single Use Only. Assembled in USA by Medline Industries, Inc., Mundelein, IL 6060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 90 cases | Class II | Terminated |
| D-0317-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 9,000 cases | Class II | Terminated |
| D-0259-2018 | 09-21-2017 | Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 51 cases | Class II | Terminated |
| D-0257-2018 | 09-21-2017 | Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 288 cases | Class II | Terminated |
| D-0308-2018 | 09-21-2017 | Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 808 cases | Class II | Terminated |
| D-0293-2018 | 09-21-2017 | Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 100 cases | Class II | Terminated |
| D-0306-2018 | 09-21-2017 | Medline Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 60 cases | Class II | Terminated |
| D-0295-2018 | 09-21-2017 | Medline General Purpose Instrument Set, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 3,300 cases | Class II | Terminated |
| D-0273-2018 | 09-21-2017 | Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 280 cases | Class II | Terminated |
| D-0291-2018 | 09-21-2017 | Medline Straight Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 10,298 cases | Class II | Terminated |
| D-0284-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 1,133 cases | Class II | Terminated |
| D-0260-2018 | 09-21-2017 | Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 50 cases | Class II | Terminated |
| D-0268-2018 | 09-21-2017 | Medline I&D Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 40 cases | Class II | Terminated |
| D-0319-2018 | 09-21-2017 | Medline Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 73 cases | Class II | Terminated |
| D-0277-2018 | 09-21-2017 | Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 250 cases | Class II | Terminated |
| D-0296-2018 | 09-21-2017 | Liberator Medical Supply Catheter Insertion Tray, Sterile, Single Use Only. Distributed by: Liberator Medical Supply, INC. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 20,430 cases | Class II | Terminated |
| D-0313-2018 | 09-21-2017 | Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 779 cases | Class II | Terminated |
| D-0290-2018 | 09-21-2017 | Medline Skin Staple Remover Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 550 cases | Class II | Terminated |
| D-0316-2018 | 09-21-2017 | Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 144 cases | Class II | Terminated |
| D-0267-2018 | 09-21-2017 | Medline Incision and Drainage Tray Kit, Sterile, Single use only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 11 cases | Class II | Terminated |
| D-0310-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 195,448 cases | Class II | Terminated |
| D-0285-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 3800 cases | Class II | Terminated |
| D-0282-2018 | 09-21-2017 | Medline Staple Remover Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 248 cases | Class II | Terminated |
| D-0262-2018 | 09-21-2017 | Medline Trunk Kit, Non-sterile. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 231 cases | Class II | Terminated |
| D-0279-2018 | 09-21-2017 | Medline Laceration Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 600 cases | Class II | Terminated |
| D-0301-2018 | 09-21-2017 | Medline Skin Biopsy Pack-LF, Sterile, Single Use Only. Packaged in USA by Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 120 cases | Class II | Terminated |
| D-0288-2018 | 09-21-2017 | Medline NICC Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 346 cases | Class II | Terminated |
| D-0269-2018 | 09-21-2017 | Medline Sheath Removal Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60063 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 40 cases | Class II | Terminated |
| D-0307-2018 | 09-21-2017 | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 49,587 cases | Class II | Terminated |
| D-0255-2018 | 09-21-2017 | Medline Vitrectomy CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 5 cases | Class II | Terminated |
| D-0256-2018 | 09-21-2017 | Medline RAD NECK ENT TRAY Pack, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 4 cases | Class II | Terminated |
| D-0263-2018 | 09-21-2017 | Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 1,000 cases | Class II | Terminated |
| D-0272-2018 | 09-21-2017 | Medline DC Line Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 363 cases | Class II | Terminated |
| D-0275-2018 | 09-21-2017 | Medline Circumcision Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Medline Industries Inc / 80 cases | Class II | Terminated |
