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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 16801–16820 of 17,860 recalls

Class IITerminated

Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

May 2, 2013 · DrugView details →

Class IITerminated

Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.

Hospira Inc.

Presence of Particulate Matter: visible particles were identified floating in the primary container.

May 2, 2013 · DrugView details →

Class IITerminated

Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

May 2, 2013 · DrugView details →

Class IITerminated

Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

May 2, 2013 · DrugView details →

Class IITerminated

MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

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