Why it was recalled
CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
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.
Lot numbers, UPCs & expiration codes
Lot JZ28, Exp 03/13
Where it was sold
Nationwide, Bahamas, and Turks & Caicos Islands
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-307-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 4, 2013
- FDA report date
- May 8, 2013
- Quantity
- 480 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Carib Import & Export, Inc.
Original FDA data
Every field from FDA enforcement report D-307-2013, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 64634
- Address
- 3020 NW 75th St
- Code information
- Lot JZ28, Exp 03/13
- Postal code
- 33147-5912
- Report date
- May 8, 2013
- Product type
- Drugs
- Recall number
- D-307-2013
- Classification
- Class II
- Recalling firm
- Carib Import & Export, Inc.
- Product quantity
- 480 bottles
- Termination date
- Aug 7, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide, Bahamas, and Turks & Caicos Islands
- Recall initiation date
- Feb 4, 2013
- Center classification date
- May 1, 2013