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Safety Alerts
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

NDC 0031-8679-01
(Commercial trade package) Lots:
9821 1/2001
9821A 1/2001
9822 4/2001
9822A 4/2001
(Contained in Infant Drops Combo 12 piece Shelf Extender, Lot 982331, shipped in cases)
9823 5/2001
9823B 5/2001
9924 7/2001
9925 8/2001
9926 9/2001
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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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.