Drug product
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.
D-307-2013
Product summary
- Event
- Event 64634
- Status
- Terminated
- Classification
- Class II
- Quantity
- 480 bottles
- Official record key
drug-enforcement:D-307-2013
Official wording
Reason: CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
Code information: Lot JZ28, Exp 03/13
Distribution pattern: Nationwide, Bahamas, and Turks & Caicos Islands
Derived failure modes
-
Manufacturing or process control
CGMP Deviations