D-0014-2015 Class III Terminated

Recalled by Bracco Diagnostic Inc — Monroe Township, NJ

Recall Details

Product Type
Drugs
Report Date
October 15, 2014
Initiation Date
September 18, 2014
Termination Date
June 30, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
58,050 packets

Product 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

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot # F12C01; Exp. 02/15