Class II · Moderate risk
E-Z-Paste Barium Sulfate Esophageal Cream
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
VoLumen Barium Sulfate Suspension
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Stability Testing: This product is below specification for preservative content.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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.
Affected NDC
32909-0945-03
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Bracco Diagnostics Inc
- NDC code
- 32909-945-03
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1083-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Bracco Diagnostics Inc
All 2013 recalls
Class III · Low risk
Tagitol V Barium Sulfate Suspension
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Class II · Moderate risk
Gastrografin
Presence of foreign substance: One lot of the product may contain black foreign particles
Class II · Moderate risk
Cardiogen-82
GMP deviation; Sr-82 levels exceeded alert limit specification
Other stability / shelf life recalls from 2013
All stability / shelf life recalls
Class III · Low risk
Fluconazole Oral Suspension
Failed Stability Specifications: this product is below specification for preservative content.
Class III · Low risk
Acyclovir Oral Suspension
Failed Stability Specification; product viscosity and or pH are below specification.
Class III · Low risk
Tagitol V Barium Sulfate Suspension
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Class II · Moderate risk
Pyridostigmine Bromide Tablets 60 mg
Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
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