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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 11301–11320 of 17,816 recalls

Class ITerminated

Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818

Sperian Eye & Face Protection, Inc

Non Sterility; contaminated with Klebsiella pneumoniae

August 16, 2016 · DrugView details →

Class IITerminated

DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20

Hospira Inc.

Discoloration: Firm received complaints of product discoloration and particulates.

August 15, 2016 · DrugView details →

Class IITerminated

Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.

Allergy Laboratories, Inc.

Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.

August 10, 2016 · DrugView details →

Class IITerminated

Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.

Pharmatech LLC

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

August 8, 2016 · DrugView details →

Class IITerminated

Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08.

Pharmatech LLC

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

August 8, 2016 · DrugView details →

Class IITerminated

Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1025-47.

Pharmatech LLC

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

August 8, 2016 · DrugView details →

Class IITerminated

Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-032-16.

Pharmatech LLC

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

August 8, 2016 · DrugView details →

Class IITerminated

Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1000-59.

Pharmatech LLC

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

August 8, 2016 · DrugView details →

Class IITerminated

Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-033-16.

Pharmatech LLC

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

August 8, 2016 · DrugView details →

Class IITerminated

Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09.

Pharmatech LLC

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

August 8, 2016 · DrugView details →

Class IIITerminated

Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86

Teva North America

Failed Impurities/Degradation Specifications.

August 5, 2016 · DrugView details →

Class IIITerminated

buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03

Amerisource Health Services

Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.

August 4, 2016 · DrugView details →

Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02

Hospira Inc., A Pfizer Company

Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.

August 4, 2016 · DrugView details →

Class IIITerminated

Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01

Genzyme Corporation / Genzyme Biosurgery

Labeling: Incorrect or Missing Lot and/or Exp. Date

August 4, 2016 · DrugView details →

Class IITerminated

Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90

Aurobindo Pharma USA Inc

Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.

August 3, 2016 · DrugView details →

Class IITerminated

Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.

Golden State Medical Supply Inc.

Failed Dissolution Specifications: Out-of-specification results in retained sample.

August 3, 2016 · DrugView details →

Class IIITerminated

Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60

Reckitt Benckiser LLC

Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.

August 3, 2016 · DrugView details →

Class IITerminated

Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90

Golden State Medical Supply Inc.

Failed Dissolution Specifications: Out-of-specification results in retained sample.

August 3, 2016 · DrugView details →

Class IIITerminated

BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05

Zydus Pharmaceuticals USA Inc

Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.

August 3, 2016 · DrugView details →

Class IIITerminated

Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82

Actavis Inc

Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).

August 2, 2016 · DrugView details →

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