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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Event Detail

Event ID 64634
Product Type Drugs
Status Ongoing
Recalling Firm Carib Import & Export, Inc.
City Miami
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-04
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide, Bahamas, and Turks & Caicos Islands

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot JZ28, Exp 03/13 Class II CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices. 480 bottles D-307-2013