Recalls / Class III
Class IIID-0014-2015
Product
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
- Brand name
- E-z-gas
- Generic name
- Antacid/antiflatulent
- Active ingredients
- Anhydrous Citric Acid, Dimethicone, Silicon Dioxide, Sodium Bicarbonate
- Route
- Oral
- NDC
- 10361-793
- FDA application
- M001
- Affected lot / code info
- Lot # F12C01; Exp. 02/15
Why it was recalled
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Recalling firm
- Firm
- Bracco Diagnostic Inc
- Manufacturer
- E-Z-EM, INC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 259 Prospect Plains Road, Building H, Monroe Township, New Jersey 08831
Distribution
- Quantity
- 58,050 packets
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-09-18
- FDA classified
- 2014-10-09
- Posted by FDA
- 2014-10-15
- Terminated
- 2015-06-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0014-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.