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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
| D-1284-2015 | 07-24-2015 | Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH 45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France. Package NDCs: 66993-472-02; 66993-473-02; 66993-475-02; 59630-501-10 | Failed Dissolution Specifications | Shionogi Inc. / a) 483 bottles; b) 5,631 bottles | Class III | Terminated |
| D-1279-2015 | 07-24-2015 | COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inhaler, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0024-02. Package NDCs: 0597-0024-02 | Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray. | Boehringer Ingelheim Roxane Inc / 358,647 inhalers | Class II | Terminated |
| D-0095-2016 | 07-24-2015 | HYDROXOCOBALAMIN (PRESERVATIVE FREE) UNIT DOSE SYRINGES, Injectable Solution, 1.5 mg/0.25 mL, 20 mL syringes, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 11 syringes | Class II | Terminated |
| D-0122-2016 | 07-24-2015 | SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/9/9MG/9ML, 9 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 41 syringes | Class II | Terminated |
| D-0107-2016 | 07-24-2015 | METHYLCOBALAMIN MDV, Injectable Solution, 5 MG/ML, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 6 syringes | Class II | Terminated |
| D-0111-2016 | 07-24-2015 | PAPAVERINE/PHENTOLAMINE, Injectable Solution, 30MG/1MG/ML, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 8 syringes | Class II | Terminated |
| D-0099-2016 | 07-24-2015 | HYDROXYCOBALAMINE/METHYLCOBALAMINE PF UNIT DOSE, Injectable Solution, 1.5/1.5 mg/0.25 mL per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 5 syringes | Class II | Terminated |
| D-0124-2016 | 07-24-2015 | TESTOSTERONE, Pellet, 200 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 298 pellet | Class II | Terminated |
| D-0074-2016 | 07-24-2015 | DEXPANTHENOL, Injectable Solution, 250 MG/ML, 30 mL syringes, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 6 syringes | Class II | Terminated |
| D-0118-2016 | 07-24-2015 | PROGESTERONE, Pellet, 50mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 5 pellets | Class II | Terminated |
| D-0096-2016 | 07-24-2015 | HYDROXOCOBALAMIN (PRESERVATIVE FREE) UNIT DOSE SYRINGES, Injectable Solution, 3 mg/0.25 mL, syringe sizes: 20 mL and 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 3 (30mL) syringes, 1 (20mL) syringe | Class II | Terminated |
| D-0086-2016 | 07-24-2015 | ESTRADIOL, Pellet, 6 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 79 pellets | Class II | Terminated |
| D-0064-2016 | 07-24-2015 | CHORIONIC GONADOTROPIN, Injectable Solution, 200 UNITS/0.1 ML, vial sizes: 4 mL; 5 mL; 6 mL; 7.5 mL ; 9 mL, 10 mL; 12 mL; 15 mL; 20 mL; 28 mL; Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 9 (4mL), 4 (5mL) vials, 9 (6mL) vials, 5 (7.5mL) vials, 4 (10mL) vials, 5 (9mL) vials, 3 (12mL) vials, 2 (15mL) vials, 1 (20mL), 1 (28mL) vials | Class II | Terminated |
| D-0121-2016 | 07-24-2015 | SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/5.4/5.4MG/9ML, 9mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 165 syringes | Class II | Terminated |
| D-0094-2016 | 07-24-2015 | GLYCOPYRROLATE, Injectable Solution, 0.2 mg/mL, 300 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 2 syringes | Class II | Terminated |
| D-0116-2016 | 07-24-2015 | PROGESTERONE, Pellet, 100 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 21 pellets | Class II | Terminated |
| D-0079-2016 | 07-24-2015 | ESTRADIOL, Pellet, 12 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 1 pellet | Class II | Terminated |
| D-0148-2016 | 07-24-2015 | TRIMIX, injectable Solution, 20MG/1MG/20MCG/ML, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 155 syringes | Class II | Terminated |
| D-0105-2016 | 07-24-2015 | METHYLCOBALAMIN MDV, Injectable Solution, 1 MG/ML, syringe sizes: 4 mL; 10 mL; 12 mL; 15mL; 30 mL; 50 mL; and 60 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 1 (4mL) syringe, 5 (10mL) syringes, 1 (12mL) syringe, 4 (15mL) syringes, 13 (30mL) syringes, 2 (50mL) syringes, 3 (60mL) syringes | Class II | Terminated |
| D-0112-2016 | 07-24-2015 | PAPAVERINE/PHENTOLAMINE/ATROPINE/PROSTAGLANDIN, Injectable Solution, 9 MG/1 MG/0. 1MG/10MCG/ML, syringe 10 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 1 syringe | Class II | Terminated |
| D-0060-2016 | 07-24-2015 | CALM ME VITAMIN COCKTAIL, MAGNESIUM, COMPOUNDED B COMPLEX, Injectable Solution, 30 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 4 vials | Class II | Terminated |
| D-0137-2016 | 07-24-2015 | TESTOSTERONE, Pellet, 70 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 6 pellets | Class II | Terminated |
| D-0109-2016 | 07-24-2015 | METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED, Injectable Solution,1 mg/mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 36 syringes | Class II | Terminated |
| D-0076-2016 | 07-24-2015 | DMPS (DIMERCAPTO-PROPANESULFONIC NA (SINGLE USE ONLY), Injectable Solution, 500 mg/mL, 5mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 1 syringe | Class II | Terminated |
| D-0115-2016 | 07-24-2015 | PROCAINE MDV, Injectable Solution,1%, container sizes: 30mL and 300mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 1 (300mL) container, 1 (30mL) container | Class II | Terminated |
| D-0128-2016 | 07-24-2015 | TESTOSTERONE, Pellet, 112 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 91 pellets | Class II | Terminated |
| D-0097-2016 | 07-24-2015 | HYDROXOCOBALAMIN (COMPOUNDED), Injectable Solution, 1 mg/mL, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 3 syringes | Class II | Terminated |
| D-0091-2016 | 07-24-2015 | FOLIC ACID, Injectable Solution, 10 mg/mL, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 6 syringes | Class II | Terminated |
| D-0154-2016 | 07-24-2015 | VITAMIN D3 OIL, Injectable Solution, 400,000 UNITS/ML, syringe size: 20 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 4 syringes | Class II | Terminated |
| D-0082-2016 | 07-24-2015 | ESTRADIOL, Injectable Solution, 20 mg/mL, 5 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 2 syringes | Class II | Terminated |
| D-0102-2016 | 07-24-2015 | METHIONINE/CHOLINE/INOSITOL, injectable Solution, 25/50/50 MG/ML, 10 mL syringes, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 2 syringes | Class II | Terminated |
| D-0151-2016 | 07-24-2015 | TRIMIX, injectable Solution, 30MG/2MG/20MCG, syringe size: 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 10 syringes | Class II | Terminated |
| D-0073-2016 | 07-24-2015 | CYANOCOBALAMIN MDV (COMPOUNDED), Injectable Solution, 1 MG/ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 30 syringes | Class II | Terminated |
| D-0104-2016 | 07-24-2015 | METHYLCOBALAMIN, Injectable Solution, 15 MG/ML, syringe sizes: 5 mL; 6 mL; 10 mL; 15 mL; 20 mL; 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 1 (5mL) syringe, 1 (6mL) syringe, 18 (10mL), 1 (15mL) syringe, 3 (20mL) syringe, 3 (30mL) syringe | Class II | Terminated |
| D-0145-2016 | 07-24-2015 | TESTOSTERONE/ANASTROZOLE, Pellet, 120/8 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 20 pellets | Class II | Terminated |
| D-0143-2016 | 07-24-2015 | TESTOSTERONE CYPIONATE FOR SUBQ INJECTION, Injectable Solution, 200 mg/mL, syringe size: 5ml and 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 243 (10mL) syringes, 5 (5mL) syringes | Class II | Terminated |
| D-0080-2016 | 07-24-2015 | ESTRADIOL, Pellet, 18 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 1 pellet | Class II | Terminated |
| D-0133-2016 | 07-24-2015 | TESTOSTERONE, Pellet, 130 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 1 pellet | Class II | Terminated |
| D-0131-2016 | 07-24-2015 | TESTOSTERONE, Pellet, 120 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 20 pellets | Class II | Terminated |
| D-1351-2015 | 07-24-2015 | ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five). | Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution | Teva Pharmaceuticals USA / 6001 vials | Class I | Terminated |
| D-0147-2016 | 07-24-2015 | TRIMIX, injectable Solution, 15MG/.5MG/5MCG/ML, 10mL syringe, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 15 syringes | Class II | Terminated |
| D-0068-2016 | 07-24-2015 | CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 200 UNITS/0.2ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314 | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | JD & SN Inc., dba Moses Lake Professional Pharmacy / 184 syringes | Class II | Terminated |
