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-0971-2016 | 08-24-2015 | Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902. | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-0973-2016 | 08-24-2015 | Xcellerator (product not labeled) | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-1818-2015 | 08-24-2015 | Refresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt. 0.12 oz (3.5 g) tube, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612, NDC 0023-0240-04, UPC 3 00230 66704 3. Package NDCs: 0023-0240-21; 0023-0240-04; 0023-0667-04; 0023-0667-21 | Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product. | Allergan Sales, LLC / 1,154,359 tubes | Class II | Terminated |
| D-1817-2015 | 08-24-2015 | Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment, packaged in a) Net wt. 0.12 oz (3.5 g) tubes (NDC 0023-0312-04) UPC 3 0023-0312-04 2 and b) Net wt. 0.25 oz (7 g) tubes (NDC 0023-0312-07) UPC 3 0023-0312-07 3, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612. Package NDCs: 0023-0312-04; 0023-0312-07 | Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product. | Allergan Sales, LLC / 320,713 tubes | Class II | Terminated |
| D-0164-2016 | 08-24-2015 | Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc. Bellmawr, NJ 08031, Manufactured for: Blu Caribe Dorado, PR 00646 USA, NDC 0463-6000-50 (top panel) NDC 24658-312-05 (side panel) | Labeling: Wrong Bar Code | C. O. Truxton / 287 bottles | Class II | Terminated |
| D-0965-2016 | 08-24-2015 | Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containers. http://www.secretsofherbs.com. Made in the USA. | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-1154-2016 | 08-21-2015 | fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992131 | Subpotent Drug | Cantrell Drug Company / 42 syringes | Class I | Terminated |
| D-0389-2016 | 08-21-2015 | Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-01 | Discoloration | Nephron Pharmaceuticals Corp. / 32,490 cartons | Class II | Terminated |
| D-0010-2016 | 08-21-2015 | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL Package NDCs: 0487-0201-01; 0487-0201-02; 0487-0201-03; 0487-0201-60 | Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process | Nephron Pharmaceuticals Corp. / a) 85,248 cartons and b) 35,292 cartons | Class II | Terminated |
| D-1160-2016 | 08-21-2015 | HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163 | Stability Data Does Not Support Expiry | Cantrell Drug Company / 4170 syringes | Class II | Terminated |
| D-1163-2016 | 08-21-2015 | MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721 | Subpotent Drug | Cantrell Drug Company / 212 syringes | Class II | Terminated |
| D-1156-2016 | 08-21-2015 | fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in a) 1 mL syringe (NDC 52533-214-45, UPC: 0100352533214455) and b) 3 mL syringe (NDC 52533-214-60, UPC: 0100352533214608), Rx Only, Cantrell Drug Co., Little Rock, AR | Subpotent Drug | Cantrell Drug Company / a) 564 syringes and b) 1146 syringes | Class I | Terminated |
| D-1153-2016 | 08-21-2015 | Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-010-45, UPC: 0100352533010453 | Subpotent Drug | Cantrell Drug Company / a) 450 syringes and b) 1250 syringes | Class I | Terminated |
| D-1159-2016 | 08-21-2015 | HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212 | Stability Data Does Not Support Expiry | Cantrell Drug Company / 352 syringes | Class II | Terminated |
| D-1161-2016 | 08-21-2015 | LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992033 | Subpotent Drug | Cantrell Drug Company / 450 syringes | Class II | Terminated |
| D-0295-2016 | 08-21-2015 | Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10 | Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled. | Akorn, Inc. / 13,896 bottles | Class III | Terminated |
| D-1416-2015 | 08-21-2015 | Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70 | Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17). | Silarx Pharmaceutical, Inc. / 576 bottles | Class III | Terminated |
| D-1152-2016 | 08-21-2015 | fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-024-45, UPC: 0100352533024450 | Subpotent Drug | Cantrell Drug Company / 884 syringes | Class I | Terminated |
| D-1155-2016 | 08-21-2015 | fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock AR --- UPC: 9999993301 | Subpotent Drug | Cantrell Drug Company / 235 syringes | Class I | Terminated |
| D-1162-2016 | 08-21-2015 | Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455 | Subpotent Drug | Cantrell Drug Company / 3853 syringes | Class II | Terminated |
| D-1158-2016 | 08-21-2015 | fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-074-16, UPC: 0100352533074165 | Subpotent Drug | Cantrell Drug Company / 1652 syringes | Class I | Terminated |
| D-1164-2016 | 08-21-2015 | MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161 | Subpotent Drug | Cantrell Drug Company / 1570 syringes | Class II | Terminated |
| D-1157-2016 | 08-21-2015 | fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993491 | Subpotent Drug | Cantrell Drug Company / 148 syringes | Class I | Terminated |
| D-0388-2016 | 08-21-2015 | Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10 | Discoloration | Nephron Pharmaceuticals Corp. / 47,754 cartons | Class II | Terminated |
| D-0231-2016 | 08-20-2015 | RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42. | Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity. | Akorn, Inc. / 6861 Vials | Class III | Terminated |
| D-0418-2015 | 08-20-2015 | Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05 | Defective Container: There were customer complaints of cracked and leaking glass vials. | Hospira Inc. / 83,320 vials | Class II | Terminated |
| D-0599-2016 | 08-19-2015 | Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 1530 | Class II | Terminated |
| D-0589-2016 | 08-19-2015 | Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Subpotent drug. | Pharmakon Pharmaceuticals / 1150 | Class II | Terminated |
| D-0604-2016 | 08-19-2015 | Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 400 | Class II | Terminated |
| D-0609-2016 | 08-19-2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / N/A | Class II | Terminated |
| D-0592-2016 | 08-19-2015 | Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 2750 | Class II | Terminated |
| D-0596-2016 | 08-19-2015 | Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 7100 | Class II | Terminated |
| D-0602-2016 | 08-19-2015 | Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 250 | Class II | Terminated |
| D-0593-2016 | 08-19-2015 | Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Subpotent drug. | Pharmakon Pharmaceuticals / 210 | Class II | Terminated |
| D-0601-2016 | 08-19-2015 | Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 525 | Class II | Terminated |
| D-0605-2016 | 08-19-2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 378 | Class II | Terminated |
| D-0588-2016 | 08-19-2015 | Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 4123 | Class II | Terminated |
| D-0606-2016 | 08-19-2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / N/A | Class II | Terminated |
| D-0594-2016 | 08-19-2015 | Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 4100 | Class II | Terminated |
| D-0597-2016 | 08-19-2015 | Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 475 | Class II | Terminated |
| D-0607-2016 | 08-19-2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / N/A | Class II | Terminated |
| D-0598-2016 | 08-19-2015 | Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 8000 | Class II | Terminated |
| D-0608-2016 | 08-19-2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / N/A | Class II | Terminated |
| D-0603-2016 | 08-19-2015 | Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 5000 | Class II | Terminated |
| D-0590-2016 | 08-19-2015 | Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / N/A | Class II | Terminated |
| D-0595-2016 | 08-19-2015 | Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 665 | Class II | Terminated |
| D-0600-2016 | 08-19-2015 | Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 600 | Class II | Terminated |
| D-0591-2016 | 08-19-2015 | Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 5875 | Class II | Terminated |
| D-1814-2015 | 08-17-2015 | Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5 | Failed Stability Specifications: product may not meet specification limit for assay test. | Apotex Inc. / 117,644 Bottles | Class II | Terminated |
| D-1829-2015 | 08-17-2015 | Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial, Rx Only, Hartley Medical, (888) 671-2888 | Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns. | Hartley Medical Center Pharmacy, Incorporated / 14 vials | Class I | Terminated |
| D-1830-2015 | 08-17-2015 | Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888 | Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns. | Hartley Medical Center Pharmacy, Incorporated / 10 vials | Class I | Terminated |
| D-1349-2015 | 08-17-2015 | Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01. | Lack of Assurance of Sterility: Failed preservative effectiveness testing. | Bausch & Lomb, Inc. / 13,995 Bottles | Class II | Terminated |
| D-0007-2016 | 08-14-2015 | Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only, 1000 count Bottle, Manuf. For Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, NDC 66582-0312-82. | Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets. | Merck Sharp & Dohme, Wilson Facility / N/A | Class II | Terminated |
| D-1362-2015 | 08-13-2015 | Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. | GlaxoSmithKline, LLC. / 166,070 of 15g tube, 112,720 of 30 g tube | Class II | Terminated |
| D-0657-2016 | 08-13-2015 | Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605. | Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant. | Safecor Health, LLC / 132 unit dose cups | Class II | Terminated |
| D-1361-2015 | 08-13-2015 | Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. | GlaxoSmithKline, LLC. / 28,480 tubes of 15g, 12,234 tubes of 30g | Class II | Terminated |
| D-1359-2015 | 08-13-2015 | Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1526-11 | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. | GlaxoSmithKline, LLC. / 88,489 tubes | Class II | Terminated |
| D-1360-2015 | 08-13-2015 | Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1525-44 | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. | GlaxoSmithKline, LLC. / 19,520 tubes | Class II | Terminated |
| D-1350-2015 | 08-13-2015 | AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50 | Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling. | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals / 360 Bottles | Class III | Terminated |
| D-1379-2015 | 08-13-2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-313-30. Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent Drug: Subpotent atorvastatin. | Dr. Reddy's Laboratories, Inc. / 3840 Bottles | Class III | Terminated |
| D-1378-2015 | 08-13-2015 | Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent Drug: Subpotent atorvastatin. | Dr. Reddy's Laboratories, Inc. / a) 16,848 and b) 216 Bottles | Class III | Terminated |
| D-1373-2015 | 08-13-2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-323-30. Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent Drug: Subpotent atorvastatin. | Dr. Reddy's Laboratories, Inc. / 1,056 Bottles | Class III | Terminated |
| D-1377-2015 | 08-13-2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent Drug: Subpotent atorvastatin. | Dr. Reddy's Laboratories, Inc. / a) 16,080 and b) 480 Bottles | Class III | Terminated |
| D-1376-2015 | 08-13-2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent Drug: Subpotent atorvastatin. | Dr. Reddy's Laboratories, Inc. / a) 14,640 and b) 624 Bottles | Class III | Terminated |
| D-1374-2015 | 08-13-2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-320-30. Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent Drug: Subpotent atorvastatin. | Dr. Reddy's Laboratories, Inc. / 576 Bottles | Class III | Terminated |
| D-1375-2015 | 08-13-2015 | Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-317-30. Package NDCs: 43598-323-30; 43598-323-60; 43598-323-90; 43598-323-05; 43598-320-30; 43598-320-60; 43598-320-90; 43598-320-05; 43598-317-30; 43598-317-60; 43598-317-90; 43598-317-05; 43598-322-30; 43598-322-60; 43598-322-90; 43598-322-05; 43598-319-30; 43598-319-60; 43598-319-90; 43598-319-05; 43598-316-30; 43598-316-60; 43598-316-90; 43598-316-05; 43598-314-30; 43598-314-60; 43598-314-90; 43598-314-05; 43598-321-30; 43598-321-60; 43598-321-90; 43598-321-05; 43598-318-30; 43598-318-60; 43598-318-90; 43598-318-05; 43598-315-30; 43598-315-60; 43598-315-90; 43598-315-05; 43598-313-30; 43598-313-60; 43598-313-90; 43598-313-05 | Subpotent Drug: Subpotent atorvastatin. | Dr. Reddy's Laboratories, Inc. / 984 Bottles | Class III | Terminated |
| D-1426-2015 | 08-11-2015 | METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged by GSMS Incorporated, Camarillo, CA 93012, USA, NDC: 60429-118-05. | Presence of Foreign Substance: Presence of hair. | Golden State Medical Supply Inc. / 1,165 Bottles | Class III | Terminated |
| D-0296-2016 | 08-06-2015 | LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali Industry & Trade Co., Ltd | Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein. | Blue Square Market, Inc. / 25 boxes | Class I | Terminated |
| D-0297-2016 | 08-06-2015 | KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC | Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil. | Blue Square Market, Inc. / 132 boxes | Class I | Terminated |
| D-1417-2015 | 08-06-2015 | DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation, supplied in a) 0.9 fl oz, 26 mL Single Use Applicator w/urethane sponge and 2-count Cotton-tipped swabs per pouch, packaged in 20 pouches per case (NDC 17518-0011-08, UPC (01) 0 03 17518 01108 5) and b) 0.2 fl oz, 6 mL Single Use Applicator w/urethane sponge per pouch, packaged in 50 pouches per case (NDC 17518-0011-07, UPC (01) 0 03 17518 01107 8), OTC, Made in U.S.A. by 3M Health Care, 2510 Conway Ave., St. Paul, MN 55144. | Chemical contamination: Product may be contaminated with a toxic compound. | 3M Company - Health Care Business / a) 4460 cases (0.9 fl oz, 26 mL Single Use Applicator, 20 pouches per case), b) 1059 cases (2 fl oz, 6 mL Single Use Applicator, 50 pouches per case) | Class II | Terminated |
| D-1370-2015 | 08-05-2015 | Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7. Package NDCs: 51672-5281-0; 51672-5281-3; 51672-5281-4; 51672-5281-7; 51672-5281-6 | Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points. | Taro Pharmaceuticals, Inc. / 16,320 Bottles | Class III | Terminated |
| D-1325-2015 | 08-03-2015 | Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60 Package NDCs: 55111-352-30; 55111-352-60; 55111-352-01; 55111-352-05; 55111-353-30; 55111-353-60; 55111-353-01; 55111-353-05; 55111-354-30; 55111-354-60; 55111-354-01; 55111-354-05; 55111-355-30; 55111-355-60; 55111-355-01; 55111-355-05 | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 2,952 bottles | Class II | Terminated |
| D-1352-2015 | 07-30-2015 | Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10 Package NDCs: 29300-128-01; 29300-128-05; 29300-128-10; 29300-128-50; 29300-129-01; 29300-129-05; 29300-129-10; 29300-129-50; 29300-485-01; 29300-485-10 | Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets. | Unichem Pharmaceuticals Usa Inc / 4776 bottles | Class II | Terminated |
| D-1406-2015 | 07-29-2015 | Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811 | Failed Dissolution Specifications | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals / 8,705 bottles | Class II | Terminated |
| D-1346-2015 | 07-29-2015 | Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06. | CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. | Wockhardt Usa Inc. / 1704 bottles | Class II | Terminated |
| D-1347-2015 | 07-29-2015 | Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06. | CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. | Wockhardt Usa Inc. / 3378 bottles | Class II | Terminated |
| D-1430-2015 | 07-28-2015 | Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540 | Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing. | Novartis Pharmaceuticals Corp. / 10,767 bottles | Class III | Terminated |
| D-0027-2016 | 07-28-2015 | Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, NDC 46122-0140-52, ABC# 059-535, UPC 0877014065546, Distributed by: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / N/A | Class III | Terminated |
| D-0032-2016 | 07-28-2015 | Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5 Package NDCs: 51660-527-31; 5166052731 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 311 boxes | Class III | Terminated |
| D-0039-2016 | 07-28-2015 | Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 5,040 boxes | Class III | Terminated |
| D-0026-2016 | 07-28-2015 | Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4. | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 12,960 boxes | Class III | Terminated |
| D-0036-2016 | 07-28-2015 | Up&Up loratadine orally disintegrating tablets, USP, 10 mg, 30-count tablets per box, Distributed by Target Corp, Minneapolis, MN 55403; NDC 11673-527-31, UPC 3 5166052731 5 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 34,488 boxes | Class III | Terminated |
| D-0033-2016 | 07-28-2015 | Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 11,232 boxes | Class III | Terminated |
| D-0035-2016 | 07-28-2015 | TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007. | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 53,688 boxes | Class III | Terminated |
| D-0025-2016 | 07-28-2015 | Equaline Original Prescription Strength, loratadine orally disintegrating tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41163-528-69, UPC 0 4116347138 2; and b) 30-count tablets per box, NDC 41163-528-31, UPC 0 4116346654 8; Distributed by: Supervalu Inc. Eden Prarie, MN 55344 USA | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 43,344 boxes | Class III | Terminated |
| D-0019-2016 | 07-28-2015 | QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 8,735 units | Class III | Terminated |
| D-0029-2016 | 07-28-2015 | HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 25,488 boxes | Class III | Terminated |
| D-0020-2016 | 07-28-2015 | Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011. | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 90,410 units | Class III | Terminated |
| D-0038-2016 | 07-28-2015 | Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 329,748 boxes | Class III | Terminated |
| D-0028-2016 | 07-28-2015 | Health Mart Pharmacy loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by: McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0073-1, UPC 0 5256913369 9 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 35,712 boxes | Class III | Terminated |
| D-0021-2016 | 07-28-2015 | Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO 64111; UPC 0 7003861209 4 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 18576 boxes | Class III | Terminated |
| D-0034-2016 | 07-28-2015 | Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 33,984 boxes | Class III | Terminated |
| D-0030-2016 | 07-28-2015 | Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 9,624 boxes | Class III | Terminated |
| D-0024-2016 | 07-28-2015 | Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by: Drug Mart-Food Fair, Medina, OH 44256, UPC 0 93351 12101 2. | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 4,176 units | Class III | Terminated |
| D-0022-2016 | 07-28-2015 | CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 21,356 boxes | Class III | Terminated |
| D-1327-2015 | 07-28-2015 | Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01 Package NDCs: 63323-614-00; 63323-614-01 | Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016) | Fresenius Kabi USA, LLC / 93,000 vials | Class III | Terminated |
| D-0037-2016 | 07-28-2015 | Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / N/A | Class III | Terminated |
| D-0031-2016 | 07-28-2015 | Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 29,360 boxes | Class III | Terminated |
| D-0023-2016 | 07-28-2015 | CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Superpotent Drug: Out Of Specification (OOS) result for Assay. | Ohm Laboratories, Inc. / 291,312 boxes | Class III | Terminated |
| D-0008-2016 | 07-27-2015 | Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for z-statistic related to mechanical peel force. | Noven Pharmaceuticals, Inc. / 125,250 Patches | Class II | Terminated |
