Status
Terminated
Drug Enforcement D-307-2013
CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
Classification
Class II
Report Date
May 8, 2013
Termination Date
August 7, 2013
Product Information
- 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.
- Product quantity
- 480 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- Nationwide, Bahamas, and Turks & Caicos Islands
Location & Firm
- Recalling firm
- Carib Import & Export, Inc.
- Address
-
3020 NW 75th St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-307-2013
- Event ID
- 64634
- Recall initiation date
- February 4, 2013
- Center classification date
- May 1, 2013
- Code info
- Lot JZ28, Exp 03/13
- More code info
- —