Class III · Low risk
E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
E-Z-CAT Dry Barium Sulfate for Suspension
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
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
E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01
Affected NDC
32909-0727-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Bracco Diagnostic Inc
- NDC code
- 32909-727-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1147-2015 · 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 Diagnostic Inc
All 2015 recalls
Class III · Low risk
E-Z-HD (barium sulfate)
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Class I · High risk
Isovue -300
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Class I · High risk
Isovue -370
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Other stability / shelf life recalls from 2015
All stability / shelf life recalls
Class III · Low risk
Ranitidine Syrup
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Class II · Moderate risk
HEPARIN Sodium in 0.45% Sodium Chloride
Stability Data Does Not Support Expiry
Class II · Moderate risk
HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE
Stability Data Does Not Support Expiry
Class II · Moderate risk
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Stability data does not support expiry.
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