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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 13721–13740 of 17,832 recalls

Class IITerminated

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) IN VERSABASE W/V (weight/volume) 4 : 67.5 :10MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

BIEST TD 83/17 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) 1.2 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · Drug

View details →

Class IITerminated

ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 4.0 MG/ML transdermal cream packaged in 3mL syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : TESTO (Testosterone USP) W/V (weight/volume) 2.0: 0.1: 0.5MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 5.0 :20 :1 MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

BIEST TD 80/20 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) W/V(weight/volume) [2977] 6.25MG/ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 8 MG/ML transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

ESTRIOL (E3) : PROGESTERONE : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 4.0 : 30 : 4MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

ESTRIOL (E3) W/V (weight/volume) VERSABASE 3MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 6.5 : 30: 1.25: 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN CR (vanishing cream) W/V (weight/volume) (4812) 2.5MG/ML Transdermal cream, dispensed in a) 1mL and b)3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5 MG/ML 1.25MG/0.1ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes,Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

the Compounder

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

March 10, 2015 · DrugView details →

Class IITerminated

Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011.

Freedom Pharmaceuticals Inc

Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.

March 10, 2015 · DrugView details →

Class IITerminated

Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84

Navinta LLC

Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.

March 9, 2015 · DrugView details →

Class ITerminated

MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.

Hospira Inc.

Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.

March 6, 2015 · DrugView details →

Class IITerminated

DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01.

Fusion Pharmaceuticals, LLC

Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.

March 6, 2015 · DrugView details →

Class ITerminated

0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.

Hospira Inc.

Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.

March 5, 2015 · DrugView details →

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