Key Takeaway

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 0 by Bracco Diagnostic Inc was recalled on September 18, 2014. The hazard: Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.

FDA Drug Class III Terminated

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 0

Recalled: September 18, 2014 ~58,050 packets units affected D-0014-2015

Description

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

Hazard / Reason

Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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 0

Drugs

Company Information

Bracco Diagnostic Inc

Princeton, NJ, United States

View all 6 recalls by Bracco Diagnostic Inc →

Distribution

Nationwide

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