FDA recall D-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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-09-18

Report date

2014-10-15

Termination date

2015-06-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Monroe Township, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0014-2015