FDAFDA · Food and drugs·Recall number D-307-2013
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.
Published May 8, 2013 · Recall initiated: February 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Carib Import & Export, Inc.
- Distributor
- Nationwide, Bahamas, and Turks & Caicos Islands
- Lot
- Lot JZ28, Exp 03/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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