US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 4, 2013 (14 years ago)

Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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.

Recalling firm
Carib Import & Export, Inc.
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-307-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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