Bracco Diagnostics

7 recalls •

• Categories: Prescription Drugs

E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01

Class I - Dangerous

Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.

Mar 8, 2018 Prescription Drugs View Details →

VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03.

Class I - Dangerous

Failed Stability Testing: This product is below specification for preservative content.

Dec 16, 2013 Prescription Drugs Nationwide View Details →

Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53

Class I - Dangerous

Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.

Jul 19, 2013 Prescription Drugs Nationwide View Details →

Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40

Class I - Dangerous

Presence of foreign substance: One lot of the product may contain black foreign particles

Jun 21, 2013 Prescription Drugs Nationwide View Details →

CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01

Class I - Dangerous

GMP deviation; Sr-82 levels exceeded alert limit specification

Jun 1, 2012 Prescription Drugs Nationwide View Details →

Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15

Class I - Dangerous

Short Fill: The product is being recalled due to a potential underfill of the affected vials.

Apr 16, 2012 Prescription Drugs Nationwide View Details →

Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17.

Class I - Dangerous

Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.

Apr 16, 2012 Prescription Drugs Nationwide View Details →