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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.

PRODUCT
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

CODE
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.

MANUFACTURER
A.H. Robins Company, Richmond, Virginia.

RECALLED BY
Whitehall-Robins Healthcare, Madison, New Jersey, by letter on July 28, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
998,486 bottles were distributed.

Safety Alerts compiles comprehensive safety recall information for the United States. SafeMail is a free email service to warn consumers of faulty products and contaminated foods. For complete information regarding current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.

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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.