D-307-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2013
- Initiation Date
- February 4, 2013
- Termination Date
- August 7, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 480 bottles
Product Description
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.
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.
Distribution Pattern
Nationwide, Bahamas, and Turks & Caicos Islands
Code Information
Lot JZ28, Exp 03/13