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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 11661–11680 of 17,816 recalls

Class IIITerminated

Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03

KVK-Tech, Inc.

Discoloration: presence of scuffing marks on tablets.

May 5, 2016 · DrugView details →

Class IITerminated

2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9276, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-276-98

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC 61553-211-08), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 61553-169-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.

Fresenius Kabi USA, LLC

Failed Impuities/Degradation Specifications

May 4, 2016 · DrugView details →

Class IITerminated

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04

Fresenius Kabi USA, LLC

Failed Impuities/Degradation Specifications

May 4, 2016 · DrugView details →

Class IIITerminated

Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01

Sandoz, Inc

Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.

May 2, 2016 · DrugView details →

Class IIITerminated

Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01

Sandoz, Inc

Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.

May 2, 2016 · DrugView details →

Class ITerminated

BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.

Making It a Lifestyle

Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.

April 29, 2016 · DrugView details →

Class IITerminated

3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.

Making It a Lifestyle

Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.

April 29, 2016 · DrugView details →

Class ITerminated

BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.

Making It a Lifestyle

Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.

April 29, 2016 · DrugView details →

Class IITerminated

Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30

Lymol Medical

Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.

April 28, 2016 · DrugView details →

Class IITerminated

Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.

Pfizer Inc.

Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.

April 28, 2016 · DrugView details →

Class IITerminated

Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454

Teva North America

Lack of Assurance of Sterility: Due to potential for leaking bags.

April 27, 2016 · DrugView details →

Class IIITerminated

Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1

Genzyme Corporation / Genzyme Biosurgery

Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.

April 27, 2016 · DrugView details →

Class IITerminated

Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21

Novo Nordisk Inc

Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step

April 27, 2016 · DrugView details →

Class IITerminated

Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37

Fresenius Kabi USA, LLC

Presence of Particulate Matter: Glass particulate found in sterile injectable product

April 25, 2016 · DrugView details →

Class IIITerminated

CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523

Dr. Reddy's Laboratories, Inc.

Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.

April 22, 2016 · DrugView details →

Class IIITerminated

Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0

A-S Medication Solutions LLC.

Labeling: Not elsewhere classified - count on the label was incorrect.

April 22, 2016 · DrugView details →

Class IITerminated

Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0806-02

Pharmakon Pharmaceuticals, Inc.

Lack of Assurance of Sterility

April 20, 2016 · DrugView details →

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