February 2013 FDA Recall Drug by Carib Import & Export, Inc.
D-307-2013 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Carib Import & Export, Inc. on February 4, 2013 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-307-2013

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.
Initiated
02-04-2013
Reported
05-08-2013
Quantity
480 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64634
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carib Import & Export, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Bahamas, and Turks & Caicos Islands
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-07-2013
Product Description About Product Description
Full technical description of the product.
Benjamins 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.

Batch or Lot Expiration Information

Lot# Lot JZ28, Exp 03/13