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November 15, 2001

Vintage Pharmaceuticals Recalls Cough Suppressant

Huntsville, AL  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Vintage Pharmaceuticals, Inc. is recalling Cough Suppressant.

This is the first public notice of this Class llI recall issued by the FDA.

Cheratussin AC Expectorant Cough Suppressant, Sugar Free containing Guaifenesin, USP (100mg/5mL), Codeine Phosphate, USP (10mg/5mL), and Alcohol, 3.5%. The product is manufactured under three names: Qualitest, Vintage, and Zenith: Goldline (Zenith Goldline uses the name, Guaituss AC Syrup, in place of Cheratussin),

Recall #D-031-2.


Lot Number, Suffix, NDC Numbers
012J9 A 0603-1075-56
012J9 B 0603-1075-58
012J9 C 0603-1075-56
017K9 A 0603-1075-58
018K9 A 0603-1075-58
005L9 B 0603-1075-54
005L9 C 0603-1075-56
005L9 D 0603-1075-56
006L9 A 0603-1075-58
038M9 A 0603-1075-58
039M9 A 0603-1075-56
039M9 C 0603-1075-54
039M9 D 0603-1075-54
011B0 A 0603-1075-56
012B0 A 0603-1075-60
012B0 F 0603-1075-58
003A0 B 0603-1075-58
004A0 B 0603-1075-54
004A0 C 0603-1075-56
004A0 D 0603-1075-60
023F0 B 0603-1075-54
008G0 A 0603-1075-54
008G0 B 0603-1075-60
008G0 D 0603-1075-58
012H0 C 0603-1075-58
012H0 D 0603-1075-54
012H0 E 0603-1075-58
045J0 A 0603-1075-58
046K0 A 0603-1075-58
046K0 C 0603-1075-54
046K0 D 0603-1075-56
002L0 A 0603-1075-58
016M0 A 0603-1075-58
019M0 A 0603-1075-54
019M0 C 0603-1075-58
043M0 B 0603-1075-54
043M0 C 0603-1075-56
043M0 E 0603-1075-58
024A1 D 0603-1075-58
062A1 B 0603-1075-54
062A1 C 0603-1075-56
062A1 E 0603-1075-60
062A1 F 0603-1075-56
036B1 A 0603-1075-56
036B1 C 0603-1075-58
037B1 A 0603-1075-58
059B1 A 0603-1075-58
023F1 A 0603-1075-54
027G1 A 0603-1075-54

Lot Number, Suffix, NDC Numbers
011B0 B 0254-9064-58
012B0 B 0254-9064-62
012B0 E 0254-9064-58
012B0 G 0254-9064-53
003A0 C 0254-9064-58
008G0 C 0254-9064-62
008G0 E 0254-9064-58
012H0 A 0254-9064-62
012H0 B 0254-9064-58
024A1 A 0254-9064-53
024A1 C 0254-9064-58
044D1 A 0254-9064-58
044D1 B 0254-9064-62
012F1 A 0254-9064-58

Zenith Goldline
Lot Number Suffix NDC Numbers
018K9 B 0182-0017-40
005L9 A 0182-0017-37
039M9 B 0182-0017-37
011B0 C 0182-0017-40
012B0 C 0182-0017-37
012B0 D 0182-0017-40
003A0 A 0182-0017-40
004A0 A 0182-0017-37
023F0 A 0182-0017-37
046K0 B 0182-0017-37
046K0 E 0182-0017-40
043M0 A 0182-0017-37
043M0 D 0182-0017-40
024A1 B 0182-0017-37
062A1 B 0182-0017-37
036B1 B 0182-0017-40
059B1 B 0182-0017-40
007E1 A 0182-0017-37
007E1 B 0182-0017-40

Vintage Pharmaceuticals, Inc. Huntsville, AL, by letter dated October 1, 2001. Firm initiated recall is ongoing.

Subpotency (Codeine Phosphate ingredient at 12 month stability).

15,860,150 ounces.

Nationwide and Puerto Rico

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.