All Recalls

Urban Remedy is voluntarily recalling Non-Dairy Spiced Golden Milk that was mislabeled as cold pressed apple juice. The ingredient list does not list tree nuts.

Apr 25, 2017 Produce View Details →

Goya Octopus in Olive Oil, Pulpo en Aceite de Oliva, NET WT./PESO NETO 4 oz. (113g), PRODUCT OF SPAIN "WILD FISH", GOYA FOODS, INC., Secaucus N.J. 07096.

Tradewind Foods de Puerto Rico

🍎 Food Class I - Dangerous

Product label states name and ingredients as octopus and real content is squid.

Mar 3, 2017 Seafood View Details →

Source Naturals Dietary Supplement Vitamin D-3; Bioactive Form for Bone and Immune Health 2000 IU per serving, 500% DV. Other ingredients: Vegetable Glycerin, Deionized water, citric acid, Natural orange flavor and lemon essential oil. Use 5 drops once daily in a drink. Packed in glass bottles in the following sizes: Unit Size 1 fl. oz. (29.57 mL), UPC 0 21078 02274 9; 2 fl. oz. (59.14 mL) - UPC 0 21078 02275 6 4 fl. oz. (118.28 mL), UPC 0 21078 02276 3 glass bottles: Codes: 1 ounce glass bottle: SN2274; XUB078; 2 ounce glass bottle: SN2275; 4 ounce glass bottle: SN2276. Manufactured for: Source Naturals, Santa Cruz, CA.

Threshold Enterprises

🍎 Food Class I - Dangerous

Testing of Vitamin D-3 as a result of a consumer complaint found specific lots to have lower concentrations than product specifications of ingredient labeling.

Dec 12, 2016 Produce Nationwide View Details →

Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807

Amneal Pharmaceuticals

💊 Drugs Class I - Dangerous

Failed Dissolution Specifications

Dec 12, 2016 Prescription Drugs Nationwide View Details →

Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04

The Harvard Drug Group

💊 Drugs Class I - Dangerous

Superpotent Drug; out of specification results for assay (manufacturer)

Dec 27, 2016 Prescription Drugs Nationwide View Details →

Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.

Fagron

💊 Drugs Class I - Dangerous

Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.

Apr 17, 2017 Prescription Drugs Nationwide View Details →

EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.

Meridian Medical Technologies a Pfizer Company

💊 Drugs Class I - Dangerous

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

Mar 12, 2017 Prescription Drugs Nationwide View Details →

Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61

The Harvard Drug Group

💊 Drugs Class I - Dangerous

Failed Dissolution Specifications

Jan 5, 2017 Prescription Drugs Nationwide View Details →

Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61

The Harvard Drug Group

💊 Drugs Class I - Dangerous

Failed Dissolution Specifications

Jan 5, 2017 Prescription Drugs Nationwide View Details →

Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16

Akorn

💊 Drugs Class I - Dangerous

Failed Dissolution Specifications

Mar 13, 2017 Prescription Drugs Nationwide View Details →

EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS: Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.

Meridian Medical Technologies a Pfizer Company

💊 Drugs Class I - Dangerous

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

Mar 12, 2017 Prescription Drugs Nationwide View Details →

Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072, UPC 3-59726-72025-0; (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24, UPC 0-75450-12369-2; (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24, UPC 3-59726-72025-0; (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24, UPC 8-83967-39839-3.

P & L Development

💊 Drugs Class I - Dangerous

Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.

Apr 17, 2017 Over-the-Counter Nationwide View Details →

ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.

Roho

🏥 Medical Devices Class I - Dangerous

When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely affect the setup process resulting in an improper cushion setup. Sitting on an over inflated or under inflated Sensor Ready Cushion may reduce or eliminate the benefits provided by the cushion, increasing the risk to skin or to other soft tissue.

Mar 20, 2017 Other Medical Devices Nationwide View Details →