September 14, 1999
Robitussin Cough & Cold Infant Drops Recalled
Madison, NJ (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Whitehall-Robins Healthcare is recalling
Robitussin Cough & Cold Infant Drops because of mislabeling. The dosage
recommendation incorrectly states "do not exceed 6 doses in a 24 hour period,"
rather than the correct 4 doses in a 24 hour period.
Robitussin Cough & Cold Infant Drops
(Guaifenesin, USP 100/ Pseudoephedrine Hydrochloride, USP 15 mg and Dextromethorphan
Hydrobromide, USP 5 mg), 1 FL. OZ. (30 mL) bottle.
Recall #D-420-9. Class II
(Commercial trade package) Lots:
(Contained in Infant Drops Combo 12 piece Shelf Extender, Lot 982331, shipped in
NDC 0031-8679-02 (Complimentary sample package) Lot:
9821 EXP 1/2001.
A.H. Robins Company, Richmond, Virginia.
Whitehall-Robins Healthcare, Madison, New Jersey, by letter on July 28, 1999.
Firm-initiated recall ongoing.
998,486 bottles were distributed.
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