Product Description

Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP, 0.005 mL), 120 mL bottle

Manufactured by: P.A. Benjamin Manufacturing Co. Ltd., 97 East Street, Kingston, JAMAICA; UPC 0 83276 34324 8.

Recall Number D-307-2013

Classification Class II

Code Info Lot JZ28, Exp 03/13

Product Distributed Qty 480 bottles

Reason For Recall CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.

Event Id 64634

Product Type Drugs

Status Ongoing

Recalling Firm Carib Import & Export, Inc., Miami FL, USA

Voluntary / Mandated Voluntary: Firm Initiate
Recall Initiation Date 2013-02-04

Initial Firm Notification of Consignee or Public

Distribution Pattern Nationwide, Bahamas, and Turks & Caicos Islands