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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 9901–9920 of 17,793 recalls

Class IITerminated

Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC 69804-024-14), 2 oz Liquid Gel (NDC 69804-024-15), 4 oz Liquid Gel (NDC 69804-024-16) bottles, Manufactured by Pain Relief Naturally, www.Naturally HL.com

Ridge Properties, LLC

GMP Deviations: inadequate manufacturing control processes

November 3, 2017 · DrugView details →

Class IITerminated

Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06), 1 oz Balm (NDC 69804-008-05), 2 oz Balm(NDC 69804-008-02), and 4 oz Balm(NDC 69804-008-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com

Ridge Properties, LLC

GMP Deviations: inadequate manufacturing control processes

November 3, 2017 · DrugView details →

Class IITerminated

Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2 oz Balm(NDC 69804-014-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com

Ridge Properties, LLC

GMP Deviations: inadequate manufacturing control processes

November 3, 2017 · DrugView details →

Class IITerminated

Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 69804-018-11), and 4 oz Gel (NDC 69804-018-12) jars, Manufactured by Pain Relief Naturally, www.Naturally HL.com

Ridge Properties, LLC

GMP Deviations: inadequate manufacturing control processes

November 3, 2017 · DrugView details →

Class IIITerminated

bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05

Mylan Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.

November 3, 2017 · DrugView details →

Class IITerminated

Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08), 1 oz Spray (NDC 69804-015-07), 2 oz Spray (NDC 69804-015-01) and 4 oz Spray (NDC 69804-015-04) bottles, Manufactured by Pain Relief Naturally, www.Naturally HL.com

Ridge Properties, LLC

GMP Deviations: inadequate manufacturing control processes

November 3, 2017 · DrugView details →

Class IIITerminated

Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023

Dr. Reddy's Laboratories, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle

October 30, 2017 · DrugView details →

Class IITerminated

ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC 71030-0003-10 and NDC 71030-0003-20, and b) 25-count cartons, NDC 71030-0003-21 and NDC 71030-0003-12, Rx Only, PharMEDium Services, LLC, 913 N. Davis Ave, Cleveland, MS, Code 2R3304.

Pharmedium Services, LLC

Subpotent Drug

October 30, 2017 · DrugView details →

Class IIITerminated

Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06

Jubilant Cadista Pharmaceuticals, Inc.

Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.

October 30, 2017 · DrugView details →

Class ITerminated

Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20

Fresenius Kabi USA, LLC

Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL

October 27, 2017 · DrugView details →

Class IITerminated

Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967

Fagron, Inc

cGMP Deviations: lack of quality assurance at the API manufacturer.

October 25, 2017 · DrugView details →

Class IITerminated

Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.

Teva Pharmaceuticals USA

Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.

October 25, 2017 · DrugView details →

Class IITerminated

Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01

Amerisource Health Services

Presence of Foreign Tablets/Capsules.

October 24, 2017 · DrugView details →

Class IITerminated

Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA

Ace Surgical Supply Co., Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag

October 24, 2017 · DrugView details →

Class IITerminated

Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30

Pfizer Inc.

SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent

October 20, 2017 · DrugView details →

Class ITerminated

diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977

Pfizer Inc.

SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent

October 20, 2017 · DrugView details →

Class IITerminated

fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64

SCA Pharmaceuticals, LLC

Lack Of Assurance Of Sterility.

October 19, 2017 · DrugView details →

Class IIITerminated

Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..

Allergan Sales, LLC

Failed Impurities/Degradation Specifications.

October 19, 2017 · DrugView details →

Class IITerminated

oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44

SCA Pharmaceuticals, LLC

Lack Of Assurance Of Sterility.

October 19, 2017 · DrugView details →

Class IITerminated

fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40

SCA Pharmaceuticals, LLC

Lack Of Assurance Of Sterility.

October 19, 2017 · DrugView details →

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