Distributors, Inc. Recalls Apetonil Jarabe
August 17, 1999
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.
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).
All lot codes.
Laboratorio MAGNECHEM International, S.A., Zone Industrial de Haina, Republica
Castillo Distributors, Inc., Little Ferry, New Jersey, by telephone and letter on
November 17, 1998. Firm-initiated recall complete.
3,470 120mL-bottles (Total of 2,622 bottles of Apetonil Jarabe Infantil, and 846
bottles of Apetonil Jarabe Para Adultos) were distributed.