CLASS III Drug recall · Reported 15 Oct 2014 · FDA Enforcement Report
E-z- Gas II Effervescent Granules Antacid/Antiflatulent recalled
Bracco Diagnostic is recalling E-z- Gas II Effervescent Granules Antacid/Antiflatulent, distributed nationwide in the US. The recall was initiated on 18 Sep 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0014-2015
- FDA event ID
- 69389
- Recalling firm
- Bracco Diagnostic, Monroe Township, NJ
- Brand
- E-z-gas
- Manufacturer
- E-Z-EM, INC.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Sep 2014
- FDA classified
- 9 Oct 2014
- Reported
- 15 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 18 Sep 2014 | Recall initiated by company | |
| 9 Oct 2014 | Classified by FDA | +21 days |
| 15 Oct 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Which lots are affected?
Lot # F12C01; Exp. 02/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bracco Diagnostic
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | E-z-cat Dry Barium Sulfate for Suspension (2% w/w after mixing) recalled | Bracco Diagnostic | Potency & Assay | Nationwide |
| Drug | CLASS III | E-z-hd (barium sulfate) For Suspension (98% w/w) recalledE-z-hd | Bracco Diagnostic | Potency & Assay | Nationwide |
| Drug | CLASS I | Isovue -300 (Iopamidol) Injection 61% Prefilled recalled | Bracco Diagnostic | Particulate Matter | Nationwide |
| Drug | CLASS I | Isovue -370 (Iopamidol) Injection 76%, Prefilled mL recalled | Bracco Diagnostic | Particulate Matter | Nationwide |
| Drug | CLASS III | Choletec - Kit for the Preparation of Technetium Tc 99m recalledCholetec | Bracco Diagnostic | Particulate Matter | Nationwide |
Other Antacid recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | E-Z-Gas II, Effervescent Granules recalled by Mckesson Medical-SurgicalE-z-gas | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Antacid Tablets, Calcium Carbonate chewable tablets, 750mg recalled | L. Perrigo | Particulate Matter | Nationwide |