Benjamins Infants Gripe Mixture Recalled for Manufacturing Violations
Carib Import & Export is recalling 480 bottles of Benjamins Infants Gripe Mixture because FDA inspections found it was not manufactured under current good manufacturing practices.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Carib Import & Export, Inc. is recalling 480 bottles of Benjamins Infants Gripe Mixture. The product is a 120 mL bottle containing light magnesium carbonate, sodium bicarbonate, sucrose, alcohol, fennel oil, and dill oil. It was manufactured by P.A. Benjamin Manufacturing Co. Ltd. in Jamaica.
The recall was initiated because an FDA inspection revealed that the product was not manufactured under current good manufacturing practices (CGMP). The specific lot number is JZ28, with an expiration date of 03/13. The product was distributed nationwide, as well as in the Bahamas and Turks & Caicos Islands.
Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- 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.…
- Manufacturer
- Carib Import & Export, Inc.
- Category
- Drug — Infant Medication
- Hazard
- Affected units
- 480
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot JZ28
- Exp 03/13
Distribution
Distributed nationwide across the United States.
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