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Safety Alerts
August 17, 1999

Castillo Distributors, Inc. Recalls Apetonil Jarabe

Little Ferry, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Castillo Distributors, Inc. is recalling Apetonil Jarabe because the products are unapproved new drugs and are misbranded as prescription products were sold over-the-counter.

PRODUCT
a) Apetonil Jarabe Para Adultos, (Cyproheptadine HCL 2.5mg/5ml) in 120 mL bottles (Appetite Stimulate Syrup for Adults);
b) Apetonil Jarabe Infantil, (Cyproheptadine HCL 1.5mg/5ml) in 120 mL bottles (Appetite Stimulate Syrup for children/infants).

Recall #D-304/305-9.

CODE
All lot codes.

MANUFACTURER
Laboratorio MAGNECHEM International, S.A., Zone Industrial de Haina, Republica Dominicana.

RECALLED BY
Castillo Distributors, Inc., Little Ferry, New Jersey, by telephone and letter on November 17, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
3,470 120mL-bottles (Total of 2,622 bottles of Apetonil Jarabe Infantil, and 846 bottles of Apetonil Jarabe Para Adultos) were distributed.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.