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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 7021–7040 of 17,773 recalls

Class IITerminated

C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Colonia Care Pharmacy

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

July 24, 2019 · DrugView details →

Class IITerminated

Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Glenmark Pharmaceuticals Inc., USA

GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.

July 23, 2019 · DrugView details →

Class IITerminated

Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Wise Pharmacy

Lack of Processing Controls

July 22, 2019 · DrugView details →

Class IITerminated

Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.

Wise Pharmacy

Lack of Processing Controls

July 22, 2019 · DrugView details →

Class IITerminated

Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Wise Pharmacy

Lack of Processing Controls

July 22, 2019 · DrugView details →

Class IITerminated

Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Wise Pharmacy

Lack of Processing Controls

July 22, 2019 · DrugView details →

Class IITerminated

Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Wise Pharmacy

Lack of Processing Controls

July 22, 2019 · DrugView details →

Class IITerminated

Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Wise Pharmacy

Lack of Processing Controls

July 22, 2019 · DrugView details →

Class IITerminated

Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Wise Pharmacy

Lack of Processing Controls

July 22, 2019 · DrugView details →

Class IITerminated

Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Wise Pharmacy

Lack of Processing Controls

July 22, 2019 · DrugView details →

Class IITerminated

Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Wise Pharmacy

Lack of Processing Controls

July 22, 2019 · DrugView details →

Class IITerminated

Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Wise Pharmacy

Lack of Processing Controls

July 22, 2019 · DrugView details →

Class IITerminated

Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Wise Pharmacy

Lack of Processing Controls

July 22, 2019 · DrugView details →

Class IITerminated

Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02

Lupin Pharmaceuticals Inc.

Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.

July 19, 2019 · DrugView details →

Class IITerminated

MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.

Dercher Enterprises, Inc., DBA Gordon Laboratories

Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.

July 19, 2019 · DrugView details →

Class IITerminated

Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ

Ascend Laboratories LLC

Failed Dissolution Specifications

July 19, 2019 · DrugView details →

Class IITerminated

Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Generic for: Maxitrol, For External Use Only, Rx only, Mfg: Paddock Laboratories, LLC, Preferred Pharmaceuticals, Inc., The Physicians Solutions, Anaheim, CA, NDC 68788-9373-03.

Preferred Pharmaceuticals, Inc

CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.

July 18, 2019 · DrugView details →

Class IIITerminated

Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)

Amneal Pharmaceuticals, Inc.

Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets

July 18, 2019 · DrugView details →

Class IITerminated

Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.

Ucb, Inc

Failed Dissolution Specifications.

July 18, 2019 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.

Baxter Healthcare Corporation

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

July 18, 2019 · DrugView details →

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