Class III · Low risk
E-Z-CAT Dry Barium Sulfate for Suspension
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409 NDC 10361-793-01
Affected NDC
10361-0793-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| E-Z-Gas II Antacid/AntiFlatulent NDC 10361-0793 |
ANHYDROUS CITRIC ACID 380 mg/g; SODIUM BICARBONATE 550 mg/g; DIMETHICONE 10 mg/g; SILICON DIOXIDE 10 mg/g | Granule, Effervescent Oral |
E-Z-Em, INC. | OTC |
- Recalling firm
- Bracco Diagnostic Inc
- NDC code
- 10361-793-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0014-2015 · 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 2014 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 wrong potency / content recalls from 2014
All wrong potency / content recalls
Class II · Moderate risk
Alprazolam tablets
Subpotent Drug
Class II · Moderate risk
Heparin Sodium in 0.9% Sodium Chloride Injection
Subpotent Drug: Heparin raw material was found to have low potency
Class III · Low risk
MethylPREDNISolone Tablets
Subpotent; 6 month stability time point
Class II · Moderate risk
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
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