Data Foundry

Drug recalls 2013

Benjamins Infants Gripe Mixture — Class II drug recall D-307-2013

Terminated recall by Carib Import & Export, Inc., reported 2013-05-08, distributed nationwide. CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufacture

Recall numberD-307-2013
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCarib Import & Export, Inc., Miami, FL, United States
Recall initiated2013-02-04
Classified2013-05-01
Reported by FDA2013-05-08
Terminated2013-08-07
DistributedNationwide (US)
Countries outside the USBS
Quantity480 bottles
Reason classescgmp
UPC / GTIN / UDI-DI00083276343248
Lot numbers03/13, JZ28

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-307-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.