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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
July 29, 1998

PRODUCT
Guaifenesin Syrup with Codeine, (Guaifenesin 100 mg/Codeine Phosphate 10 mg), in 5 mL and 10 mL unit dose and 4 and 16 fluid ounce bottles. NDC numbers: 0121-0422-05 (5 mL unit dose), 0121-0422-10 (10 mL unit dose), 0121-0422-04 (4 oz. bottles), 0121-0422-16 (16 oz. bottles). Recall #D-200-8.

CODE
: 5 mL unit dose - Lot # 6K29, 7C17, 7E37; 10 mL unit dose - Lot # 6L30, 7A36, 7B34, 7C16, 7D30, 7E38; 4 fl. oz. bottles - Lot # 6E16, 6I13, 6K28, 6L29, 7A34, 7B33, 7C15, 7D24, 7E36; 16 fl. oz. bottles - Lot # 6I14.

MANUFACTURER
Pharmaceutical Associates, Inc., Greenville, South Carolina.

RECALLED BY
Manufacturer, by letter on April 23, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
5 mL - 228,440 units; 10 mL - 97,450 units 4 oz. - 143,803 units; 16 oz. - 720 units were distributed.

REASON
Subpotent for codeine phosphate (12 month stability).

 

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.