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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00

Aurobindo Pharma USA

Class I - Dangerous

Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.

Dec 16, 2016 Prescription Drugs Nationwide View Details →

Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771.

VistaPharm

Class I - Dangerous

Defective Container: Leakage of unit dose cups that may occur at the seal.

Jan 18, 2017 Prescription Drugs Nationwide View Details →

Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12

Dr. Reddy's Laboratories

Class I - Dangerous

Failed Dissolution Specifications; 18 month stability time point

Dec 28, 2016 Prescription Drugs Nationwide View Details →

Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India

Dr. Reddy's Laboratories

Class I - Dangerous

Failed Dissolution Specifications; 18 month stability time point

Dec 28, 2016 Prescription Drugs Nationwide View Details →

Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.

VistaPharm

Class I - Dangerous

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Jan 18, 2017 Prescription Drugs Nationwide View Details →

Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.

VistaPharm

Class I - Dangerous

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Jan 18, 2017 Prescription Drugs Nationwide View Details →

Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.

VistaPharm

Class I - Dangerous

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Jan 18, 2017 Prescription Drugs Nationwide View Details →

Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India

Dr. Reddy's Laboratories

Class I - Dangerous

Failed Dissolution Specifications; 18 month stability time point

Dec 28, 2016 Prescription Drugs Nationwide View Details →

Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.

VistaPharm

Class I - Dangerous

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Jan 18, 2017 Prescription Drugs Nationwide View Details →

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771

VistaPharm

Class I - Dangerous

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Jan 18, 2017 Prescription Drugs Nationwide View Details →

Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.

VistaPharm

Class I - Dangerous

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Jan 18, 2017 Prescription Drugs Nationwide View Details →

Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.

VistaPharm

Class I - Dangerous

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Jan 18, 2017 Prescription Drugs Nationwide View Details →

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.

VistaPharm

Class I - Dangerous

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Jan 18, 2017 Prescription Drugs Nationwide View Details →

Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-counter, Model Number: 61430436 (800 mL, 12 bottles/case) - United States; Model Number: 6000179 (800 mL, 12 bottles/case) - Canada, Ecolab, St. Paul, MN 55102, NDC 47593-265-36

Ecolab

Class I - Dangerous

Subpotent Drug

Dec 2, 2016 Over-the-Counter View Details →

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.

VistaPharm

Class I - Dangerous

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Jan 18, 2017 Prescription Drugs Nationwide View Details →

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), Rx only, Manufactured by VistaPharm, Largo, FL 33771.

VistaPharm

Class I - Dangerous

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Jan 18, 2017 Prescription Drugs Nationwide View Details →

Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90

Hetero Drugs Ltd. - Unit 1

Class I - Dangerous

Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.

Dec 29, 2016 Prescription Drugs View Details →

Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771

VistaPharm

Class I - Dangerous

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Jan 18, 2017 Prescription Drugs Nationwide View Details →

Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India

Dr. Reddy's Laboratories

Class I - Dangerous

Failed Dissolution Specifications; 18 month stability time point

Dec 28, 2016 Prescription Drugs Nationwide View Details →

MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05

Fresenius Kabi USA

Class I - Dangerous

Failed Impurities/Degradation Specifications

Dec 16, 2016 Prescription Drugs Nationwide View Details →