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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 10301–10320 of 17,793 recalls

Class IITerminated

Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

CGMP Deviations

July 12, 2017 · DrugView details →

Class IIITerminated

Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.

Pfizer Inc.

CGMP Deviations: Firm failed to control impurity for color change at the API stage.

July 12, 2017 · DrugView details →

Class IIITerminated

Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.

July 11, 2017 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02.

Baxter Healthcare Corporation

Lack of Assurance of Sterility: Customer complaints for leaking bags.

July 6, 2017 · DrugView details →

Class IIITerminated

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01

Hospira Inc., A Pfizer Company

Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point

July 6, 2017 · DrugView details →

Class IITerminated

5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38

Baxter Healthcare Corporation

Lack of Assurance of Sterility: Bags have the potential to leak.

July 6, 2017 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38

Baxter Healthcare Corporation

Lack of Assurance of Sterility: Bags have the potential to leak.

July 6, 2017 · DrugView details →

Class IITerminated

Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.

Precision Dose Inc.

Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.

July 5, 2017 · DrugView details →

Class ITerminated

D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1

HARDCORE FORMULATIONS

Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.

July 5, 2017 · DrugView details →

Class ITerminated

ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0

HARDCORE FORMULATIONS

Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.

July 5, 2017 · DrugView details →

Class IIITerminated

Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.

June 29, 2017 · DrugView details →

Class IIITerminated

Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.

June 29, 2017 · DrugView details →

Class IITerminated

parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15% w/v fluoride ion), 3.4 OZ (96.4 g) tube, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059, NDC 0135-0601-01.

GSK Consumer Healthcare

Presence of Foreign Substance: possibility of the presence of metal in the product.

June 28, 2017 · DrugView details →

Class IIITerminated

Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02

Valeant Pharmaceuticals North America LLC

Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.

June 28, 2017 · DrugView details →

Class IITerminated

Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

June 26, 2017 · DrugView details →

Class IITerminated

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

June 26, 2017 · DrugView details →

Class IITerminated

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5286 NDC# 61553-286-48

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

June 26, 2017 · DrugView details →

Class IITerminated

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

June 26, 2017 · DrugView details →

Class IITerminated

Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50

VistaPharm, Inc.

Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.

June 26, 2017 · DrugView details →

Class IITerminated

Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5299 NDC# 61553-299-48

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

June 26, 2017 · DrugView details →

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