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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.

Nephron Pharmaceuticals Corporation

Class I - Dangerous

Incorrect labeling: Incorrect or missing lot and/or exp date

Oct 21, 2019 Prescription Drugs Nationwide View Details →

Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Innoveix Pharmaceuticals

Class I - Dangerous

Lack of Sterility Assurance.

Oct 10, 2019 Prescription Drugs Nationwide View Details →

Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9

Taro Pharmaceuticals U.S.A.

Class I - Dangerous

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Sep 27, 2019 Prescription Drugs Nationwide View Details →

Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.

Oct 22, 2019 Prescription Drugs Nationwide View Details →

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.

Sandoz

Class I - Dangerous

Labeling: Incorrect or missing package insert.

Oct 17, 2019 Prescription Drugs Nationwide View Details →

Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carcelen, Quito-Ecuador 170302 Distributed By: Fitoterapia USA Inc., 500 NW 141 Ave. 112 Pembroke Pines, FL 33028

FITOTERAPIA USA

Class I - Dangerous

Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

Sep 16, 2019 Other Drugs View Details →

AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

AVKARE

Class I - Dangerous

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Oct 17, 2019 Prescription Drugs View Details →

Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93

Mylan Pharmaceuticals

Class I - Dangerous

Failed Dissolution Specification: Low out of specification dissolution results.

Oct 18, 2019 Prescription Drugs Nationwide View Details →

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1

Taro Pharmaceuticals U.S.A.

Class I - Dangerous

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Sep 27, 2019 Prescription Drugs Nationwide View Details →

AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

AVKARE

Class I - Dangerous

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Oct 17, 2019 Prescription Drugs View Details →

Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8

Apotex

Class I - Dangerous

Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.

Oct 22, 2019 Prescription Drugs View Details →

Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8

Taro Pharmaceuticals U.S.A.

Class I - Dangerous

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Sep 27, 2019 Prescription Drugs Nationwide View Details →

Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.

Sandoz

Class I - Dangerous

Labeling: Incorrect or missing package insert.

Oct 17, 2019 Prescription Drugs Nationwide View Details →

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04

Taro Pharmaceuticals U.S.A.

Class I - Dangerous

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Sep 27, 2019 Prescription Drugs Nationwide View Details →

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8

Taro Pharmaceuticals U.S.A.

Class I - Dangerous

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Sep 27, 2019 Prescription Drugs Nationwide View Details →

Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Innoveix Pharmaceuticals

Class I - Dangerous

Lack of Sterility Assurance.

Oct 10, 2019 Prescription Drugs Nationwide View Details →

Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79

AuroMedics Pharma

Class I - Dangerous

CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

Sep 23, 2019 Prescription Drugs Nationwide View Details →

Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Innoveix Pharmaceuticals

Class I - Dangerous

Lack of Sterility Assurance.

Oct 10, 2019 Prescription Drugs Nationwide View Details →

Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Innoveix Pharmaceuticals

Class I - Dangerous

Lack of Sterility Assurance.

Oct 10, 2019 Prescription Drugs Nationwide View Details →

Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10

Nephron Pharmaceuticals Corporation

Class I - Dangerous

Lack of Assurance of Sterility; bags have potential to leak

Oct 9, 2019 Prescription Drugs Nationwide View Details →