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SafetyAlerts
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.

PRODUCT
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.

CODE
Codes:

Qualitest®
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

Vintage®
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

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

REASON
Subpotency (Codeine Phosphate ingredient at 12 month stability).

VOLUME OF PRODUCT IN COMMERCE
15,860,150 ounces.

DISTRIBUTION
Nationwide and Puerto Rico
.

 
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Health Professional:

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During 2000 there were over
1050 products recalled in the United
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