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-1463-2016 | 07-19-2016 | Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247 | Lack of Assurance of Sterility | Talon Compounding Pharmacy / 500 vials | Class II | Terminated |
| D-1460-2016 | 07-19-2016 | Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. Package NDCs: 68382-034-06; 68382-034-16; 68382-034-10; 68382-035-06; 68382-035-16; 68382-035-10; 68382-036-06; 68382-036-16; 68382-036-10 | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Zydus Pharmaceuticals USA Inc / 223,776 bottles | Class II | Terminated |
| D-1461-2016 | 07-19-2016 | Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. Package NDCs: 68382-034-06; 68382-034-16; 68382-034-10; 68382-035-06; 68382-035-16; 68382-035-10; 68382-036-06; 68382-036-16; 68382-036-10 | Failed Dissolution Specifications: out of specification dissolution results in retained samples | Zydus Pharmaceuticals USA Inc / N/A | Class II | Terminated |
| D-1445-2016 | 07-18-2016 | Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44, | Penicillin Cross Contamination | GlaxoSmithKline, LLC / 18,000 tubes | Class II | Terminated |
| D-1444-2016 | 07-18-2016 | Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11. | Penicillin Cross Contamination | GlaxoSmithKline, LLC / 153,119 tubes | Class II | Terminated |
| D-1443-2016 | 07-18-2016 | Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25, | Penicillin Cross Contamination | GlaxoSmithKline, LLC / 7,480 tubes | Class II | Terminated |
| D-1442-2016 | 07-18-2016 | Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-22, | Penicillin Cross Contamination | GlaxoSmithKline, LLC / 28,131 tubes | Class II | Terminated |
| D-1453-2016 | 07-15-2016 | Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324; NDC 59310-206-08. | Failed Content Uniformity Specifications: out of specification test result for spray content uniformity. | Teva North America / 193,320 canisters | Class III | Terminated |
| D-0022-2017 | 07-15-2016 | Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85 | Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia | The Harvard Drug Group / 153,432 bottles | Class I | Terminated |
| D-0112-2017 | 07-12-2016 | Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15 Package NDCs: 17772-102-70; 17772-102-01; 17772-102-30; 17772-102-15; 17772-102-10; 17772-102-12; 17772-102-07; 17772-103-70; 17772-103-01; 17772-103-30; 17772-103-15; 17772-103-10; 17772-103-12; 17772-103-07; 17772-104-70; 17772-104-01; 17772-104-30; 17772-104-15; 17772-104-12; 17772-104-10; 17772-104-07; 17772-101-70; 17772-101-01; 17772-101-30; 17772-101-15; 17772-101-10; 17772-101-12; 17772-101-07 | Superpotent Drug: Failure of assay specifications in the capsule. | Supernus Pharmaceuticals, Inc. / 17,128 (30-count blister packs) | Class II | Terminated |
| D-1448-2016 | 07-11-2016 | Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09 Package NDCs: 45963-303-09; 45963-304-09; 45963-305-09 | Failed Dissolution Specifications | Actavis Inc / 8,062 units | Class II | Terminated |
| D-0900-2017 | 07-07-2016 | Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280. | CGMP Deviations | Safecor Health, LLC / 66 bottles | Class II | Terminated |
| D-0901-2017 | 07-07-2016 | Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009 | CGMP Deviations | Safecor Health, LLC / 119 bottles | Class II | Terminated |
| D-0904-2017 | 07-07-2016 | Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205 | CGMP Deviations | Safecor Health, LLC / 856 bottles | Class II | Terminated |
| D-0903-2017 | 07-07-2016 | Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305 | CGMP Deviations | Safecor Health, LLC / 601 bottles | Class II | Terminated |
| D-0902-2017 | 07-07-2016 | Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392. | CGMP Deviations | Safecor Health, LLC / 25 bottles | Class II | Terminated |
| D-0905-2017 | 07-07-2016 | Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402 | CGMP Deviations | Safecor Health, LLC / 1,933 bottles | Class II | Terminated |
| D-1447-2016 | 07-07-2016 | Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94. | Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment. | Medicap Pharmacy / 1 bottle | Class II | Terminated |
| D-1452-2016 | 07-05-2016 | Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914. | Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph. | Let's Talk Health, Inc. / 417 bottles | Class II | Terminated |
| D-0106-2017 | 07-01-2016 | Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Dream Body Weight Loss / Unknown | Class II | Terminated |
| D-0107-2017 | 07-01-2016 | Dream Body 450 mg 30 capsules in a plastic screw on top bottle | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Dream Body Weight Loss / Unknown | Class II | Terminated |
| D-0108-2017 | 07-01-2016 | Dream Body Advanced 400 mg 30 capsules in brown foil packets. | Marketed without an approved NDA/ANDA: Undeclared sibutramine. | Dream Body Weight Loss / Unknown | Class II | Terminated |
| D-0099-2017 | 06-30-2016 | TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512. | Failed Content Uniformity Specifications | Allergan Sales, LLC / 25,247 tubes (19,499 30 gram/ 5,748 100 gram) | Class II | Terminated |
| D-1457-2016 | 06-30-2016 | Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30 | Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point. | Actavis Inc / 167,152 bottles | Class II | Terminated |
| D-0100-2017 | 06-30-2016 | TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159. | Failed Content Uniformity Specifications | Allergan Sales, LLC / 17,112 tubes | Class II | Terminated |
| D-1166-2016 | 06-29-2016 | TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers. | Vital Care Compounder, LLC / 13 units | Class II | Terminated |
| D-0169-2017 | 06-29-2016 | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01 | Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life. | Hospira Inc. / 287,200 2 mL ampules | Class III | Terminated |
| D-1480-2016 | 06-29-2016 | Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, | Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles. | Isomeric Pharmacy Solution, LLC / 274 multdose vials | Class II | Terminated |
| D-1255-2016 | 06-28-2016 | DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA, Martorelles, Barcelona --- NDC 60429-166-10 Package NDCs: 60429-164-60; 60429-165-30; 60429-165-90; 60429-166-30; 60429-166-10 | Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018 | Golden State Medical Supply Inc. / 2077 bottles | Class III | Terminated |
| D-1446-2016 | 06-27-2016 | buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86 Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13 | Failed Dissolution Specifications | Sun Pharmaceutical Industries, Inc. / 16,085 bottles | Class III | Terminated |
| D-1506-2016 | 06-27-2016 | Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 | Failed Impurities/Degradation Specifications | Sun Pharmaceutical Industries, Inc. / 612 HDPE bottles | Class III | Terminated |
| D-1504-2016 | 06-27-2016 | Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 | Failed Impurities/Degradation Specifications | Sun Pharmaceutical Industries, Inc. / 4,656 HDPE bottles | Class III | Terminated |
| D-1507-2016 | 06-27-2016 | Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 | Failed Impurities/Degradation Specifications | Sun Pharmaceutical Industries, Inc. / 3,889 HDPE bottles | Class III | Terminated |
| D-1505-2016 | 06-27-2016 | Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-count bottle (NDC 57664-244-13), 1000-count bottle (NDC 57664-244-18), Rx Only, Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 | Failed Impurities/Degradation Specifications | Sun Pharmaceutical Industries, Inc. / 2,952 HDPE bottles | Class III | Terminated |
| D-1470-2016 | 06-24-2016 | Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76 Package NDCs: 0093-2263-01; 0093-2264-01; 0093-4160-76; 0093-4160-78; 0093-4160-73; 0093-4155-79; 0093-4155-73; 0093-4155-80; 0093-4161-76; 0093-4161-78; 0093-4161-73; 0093-2267-01; 0093-2268-01; 0093-3107-01; 0093-3107-05; 0093-3109-53; 0093-3109-05 | Superpotent drug: Out of specification test result for assay during stability testing. | Teva North America / 53,328 bottles | Class II | Terminated |
| D-1359-2016 | 06-23-2016 | Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32 Package NDCs: 0409-1273-03; 0409-1273-32 | Crystallization: Product contains particulate identified to be crystallized active ingredient. | Hospira Inc. / 373,850 tubes | Class II | Terminated |
| D-0706-2017 | 06-22-2016 | Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91 | Failed Dissolution Specifications | Mylan Pharmaceuticals Inc. / 24,176 bottles (1,450,560 tablets) | Class II | Terminated |
| D-1455-2016 | 06-22-2016 | Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16 | Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material. | Teva North America / 8,052 bottles | Class II | Terminated |
| D-1508-2016 | 06-20-2016 | Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | W & C dba The Apothecary / 40,000 mL | Class II | Terminated |
| D-1509-2016 | 06-20-2016 | Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | W & C dba The Apothecary / 840 mL | Class II | Terminated |
| D-1512-2016 | 06-20-2016 | Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | W & C dba The Apothecary / 10 mL | Class II | Terminated |
| D-1510-2016 | 06-20-2016 | Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | W & C dba The Apothecary / 450 mL | Class II | Terminated |
| D-1511-2016 | 06-20-2016 | Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating. | W & C dba The Apothecary / 600 mL | Class II | Terminated |
| D-1495-2016 | 06-17-2016 | Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers) | CGMP Deviations | Teva North America / 92,480 containers | Class II | Terminated |
| D-1496-2016 | 06-17-2016 | Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01. | CGMP Deviations | Teva North America / 14,661 vials | Class II | Terminated |
| D-1497-2016 | 06-17-2016 | Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton) | CGMP Deviations | Teva North America / 13,223 vials | Class II | Terminated |
| D-1494-2016 | 06-17-2016 | ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton). | CGMP Deviations | Teva North America / 1,299 bags | Class II | Terminated |
| D-1450-2016 | 06-13-2016 | Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69 | Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution. | Sagent Pharmaceuticals Inc / 3990 vials | Class II | Terminated |
| D-0205-2017 | 06-13-2016 | Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14. | Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018. | Jubilant Cadista Pharmaceuticals, Inc. / 1512 bottles | Class III | Terminated |
| D-1059-2016 | 06-10-2016 | SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10. | Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis. | Valeant Pharmaceuticals North America LLC / 958 Bottles | Class III | Terminated |
| D-1062-2016 | 06-07-2016 | Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301, NDC 64980-0504-48 | Subpotency: product assayed and found OOS for cyproheptadine | Lyne Laboratories, Inc. / 12,215 Bottles shipped to Rising Pharmaceuticals | Class III | Terminated |
| D-1063-2016 | 06-03-2016 | Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01 Package NDCs: 55111-653-30; 55111-653-01; 55111-654-30; 55111-654-01 | Failed impurities/degradation: out of specification result for impurity secorapamycin. | Dr. Reddy's Laboratories, Inc. / 9,330 bottles | Class III | Terminated |
| D-1465-2016 | 06-02-2016 | Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY | Crystallization; complaints received by the manufacturer of crystals forming in product | Exact-Rx Inc / 6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz) | Class III | Terminated |
| D-1061-2016 | 06-01-2016 | Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01 | Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity. | Aidarex Pharmaceuticals LLC / 599 bottles | Class III | Terminated |
| D-0975-2016 | 06-01-2016 | CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01. | Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity. | Aidarex Pharmaceuticals LLC / 292 Bottles | Class II | Terminated |
| D-0974-2016 | 06-01-2016 | CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01 | CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API. | Aidarex Pharmaceuticals LLC / 10 | Class III | Terminated |
| D-1451-2016 | 05-31-2016 | mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01. | Failed Impurities/Degradation Specifications: High out of specification results for Impurity D. | Teva North America / 2,506 vials | Class III | Terminated |
| D-1049-2016 | 05-30-2016 | Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09. Package NDCs: 43547-330-03; 43547-330-09; 43547-330-50; 43547-331-03; 43547-331-09; 43547-331-50 | Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container. | Prinston Pharmaceutical Inc / 60 bottles (5 cases) | Class III | Terminated |
| D-1038-2016 | 05-28-2016 | Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11 | Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels. | Par Pharmaceutical / 12,535 bottles | Class III | Terminated |
| D-0134-2017 | 05-26-2016 | Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC | Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione. | Taro Pharmaceuticals U.S.A., Inc. / 17,100 kits | Class III | Terminated |
| D-1464-2016 | 05-26-2016 | Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL. | Crystallization; Complaints that cream appears to have crystallized | Stratus Pharmaceuticals Inc / a) 12,345 tubes; b) 8,578 tubes | Class III | Completed |
| D-1036-2016 | 05-25-2016 | Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01 | Labeling: Incorrect or Missing Package Insert | Sandoz Inc / 3,048 bottles ( 304,800 tablets) | Class III | Terminated |
| D-1032-2016 | 05-23-2016 | Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC 0 00950 86006 8. | Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top. | Valeant Pharmaceuticals North America LLC / 3827 bottles | Class III | Terminated |
| D-1030-2016 | 05-23-2016 | Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32 | Failed Dissolution Specifications | Nostrum Laboratories, Inc. / 2839 bottles | Class II | Terminated |
| D-1441-2016 | 05-19-2016 | Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41 Package NDCs: 0054-0390-41; 0054-0390-63 | Failed Impurities/Degradation Specification; 9 month stability | West-Ward Columbus Inc / 1,182 bottles | Class III | Terminated |
| D-1031-2016 | 05-19-2016 | Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30. | Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing. | Galderma Laboratories, L.P. / 71,340 Bottles | Class III | Terminated |
| D-1047-2016 | 05-18-2016 | Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada | cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration | Attix Pharmaceuticals Inc / N/A | Class III | Terminated |
| D-1449-2016 | 05-18-2016 | Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01. | Failed Tablet/Capsule Specifications | Teva North America / 14, 370 units | Class III | Terminated |
| D-1478-2016 | 05-17-2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48241-1, Shade 06 (D-G) | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. | Clinique International / 1,771,244 bottles for all shades | Class III | Terminated |
| D-1012-2016 | 05-17-2016 | TESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0991-2016 | 05-17-2016 | Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1475-2016 | 05-17-2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N) | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. | Clinique International / 1,771,244 bottles for all shades | Class III | Terminated |
| D-1026-2016 | 05-17-2016 | CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 916 total | Class II | Terminated |
| D-1028-2016 | 05-17-2016 | ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 916 total units | Class II | Terminated |
| D-0984-2016 | 05-17-2016 | ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0990-2016 | 05-17-2016 | HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0995-2016 | 05-17-2016 | M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1021-2016 | 05-17-2016 | TRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1008-2016 | 05-17-2016 | QUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0996-2016 | 05-17-2016 | M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1014-2016 | 05-17-2016 | TESTOSTERONE CYPIONATE 175MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1010-2016 | 05-17-2016 | SUPER TRI-MIX #4, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1023-2016 | 05-17-2016 | VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1002-2016 | 05-17-2016 | METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0985-2016 | 05-17-2016 | GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0978-2016 | 05-17-2016 | 17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 units (total all products) | Class II | Terminated |
| D-1000-2016 | 05-17-2016 | METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1005-2016 | 05-17-2016 | PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1017-2016 | 05-17-2016 | TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1007-2016 | 05-17-2016 | QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1022-2016 | 05-17-2016 | VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0979-2016 | 05-17-2016 | ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1024-2016 | 05-17-2016 | VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0981-2016 | 05-17-2016 | ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1027-2016 | 05-17-2016 | ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 916 total units | Class II | Terminated |
| D-1025-2016 | 05-17-2016 | QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1016-2016 | 05-17-2016 | TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1004-2016 | 05-17-2016 | PHENYLEPHERINE 0.5%, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0999-2016 | 05-17-2016 | METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1474-2016 | 05-17-2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47477-5, Shade 02 (VF-N) | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. | Clinique International / 1,771,244 bottles for all shades | Class III | Terminated |
