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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
July 22, 1998

PRODUCT
a) Q-Tussin Syrup, (Guaifenesin, USP, 100 mg/Dextromethorphan Hydrobromide, USP 10 mg), in 16 fluid ounce and 1 gallon (128 fluid ounce) bottles, under the Qualitest label, OTC. NDC 0603-0857-58, NDC 0603-0857-60;

b) Cheratussin DAC Sugar Free Syrup (Guaifenesin, USP 100mg/Pseudoephedrine HCl, USP 30 mg/Codeine Phosphate, USP 10 mg) in 16 fluid ounce plastic bottles, a liquid expectorant/ decongestant/cough suppressant packaged under the Qualitest Products and Vintage Pharmaceuticals labels; also packaged under the Goldline label as Guiatuss DAC Syrup. NDC 0603-1078-58 (Qualitest), NDC 0254-9065-58 (Vintage);

c) Guiatuss DAC-Sugar Free Syrup (Guaifenesin, USP, 100mg/Pseudoephedrine HCl, USP 30 mg/Codeine Phosphate, USP 10 mg), in 16 fluid ounce plastic bottles, packaged under the Goldline label. NDC 0182-1378-40. Recall #D-183/185-8.

CODE
Lot numbers: a) 004C7A EXP 2/99 and 004C7B EXP 2/99; b) 006A7B EXP 12/98, 010J7A EXP 8/99, 029B8A EXP 7/99, 006A7A EXP 12/98, 029B8B EXP 7/99, 030B8C EXP 7/99; c) 030B8A EXP 7/99.

MANUFACTURER
Vintage Pharmaceuticals, Inc., Huntsville, Alabama.

RECALLED BY
Manufacturer, by letter May 20, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
a) 158 128-ounce bottles and 1,488 16-ounce bottles;

b) 6,992 bottles(lot 006A7B) 15,608 bottles (Lot 010J7A), 13,780 (Lot 029B8A), 959 bottles (Lot 006A7A), 1,406 bottles (Lot 029B8B), 3,600 bottles (Lot 030B8C) were distributed.

REASON
Inability to support product shelf life through labeled expiration date.

 

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.