D-307-2013 Class II Terminated
FDA drug recall D-307-2013 was initiated by Carib Import & Export, Inc. on February 4, 2013 and is designated Class II. 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. The recall status is terminated (terminated August 7, 2013). Affected quantity: 480 bottles.
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