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
Reported: August 28, 2013 Initiated: July 19, 2013 #D-914-2013
Product Description
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
Reason for Recall
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Details
- Recalling Firm
- Bracco Diagnostics Inc
- Units Affected
- 3,096 bottles
- Distribution
- Nationwide
- Location
- Monroe Township, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Bracco Diagnostics Inc. Units affected: 3,096 bottles.
Why was this product recalled? ▼
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 28, 2013. Severity: Low. Recall number: D-914-2013.
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